Dear sir / madam,

In support of the “London Declaration on Climate Change”, the International Organization for Standardization (ISO) has assessed the need to consider the impact of Climate Change on the ability of the management system to achieve its intended results and has decided to add two new textual statements to a number of existing management system standards and to include them in all new standards under development/revision.

In line with this decision, the specifications of various ISO standards

ISO 9001:2015/Amd 1:2024

ISO 14001/Amd 1:2024

ISO 45001 AMD 1:2024

ISO 22000 AMD 1:2024

ISO 50001 AMD 1:2024

ISO IEC 27001 Amd 1:2024

Published. ( https://www.iso.org/standard/88431.html )

Articles added with the new amendment;

4.1 The organization must determine whether there is an issue related to climate change or not.

4.2 NOTE: Interested parties may have requirements regarding climate change.

As above.

What Our Certified Organizations Should Do in This Scope;

*Climate Change should be determined whether it is related to other issues, and if so, it should be evaluated within the scope of risk assessment within the scope of management systems standards.

*Where more than one management system is operated (for example, Quality Management and Health and Safety Management), Climate Change is assessed within the scope of each management system standard if it is determined to be relevant.

*It is noted that some climate change considerations and risks may be generic in nature (e.g., when related to regulatory compliance or operational adaptability and organizational resilience), regardless of the applicable management system scope or sector, while others will be indexed specifically to the requirements of management system standards for specific industries and characteristics of the organization (e.g., power generation, agriculture and fisheries), and others will be indexed specifically to the requirements of management system standards (e.g., geographic location, nature of the supply chain or labor dynamics).

Impact of the Amendment on 3rd party audits and Certification Process;

In accordance with the final text published in the Management systems audits carried out by Szutest, issues affecting Climate Change related to the organization and its context will be questioned. Where it cannot demonstrate that all internal and external issues identified as relevant, including Climate Change, have been taken into account, an appropriate finding will be provided.

Management system standards will go through the ISO amendment process, but there is no need to issue a revised certificate if the following are taken into account:

–              The publication year of each Management System standard will not change.

–              There is no change in the scope of application for the certified Management System.

–              There is no significant impact on the effectiveness of the certified Management System.

–           The method and actions that certified organizations will eventually enter into, due to the new requirement, will resemble methods and actions they would apply in the case of future changes in any other contextual issue they already address within the scope of the Management System.

For your kind information,

System Certification Department Manager 

Belma TURKEL

As SZUTEST (NoBo 2195), we have successfully completed our Notified Body authorization process within the scope of the (EU) 2016/425 Personal Protective Equipment Regulation(3), first by the Turkish Accreditation Agency and then by the Ministry of Labor and Social Security. As of April 27, 2021, our notified body authorization was published on NANDO, the official publication of the European Union Commission.

We would like to inform you that we can perform CE certification procedures with the widest product group authorization among the Notified Bodies in Türkiye within the scopes you can find the details below.

For our scope on NANDO: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1003821?organizationVersion=11

For our scope on TÜRKAK: https://portal.turkak.org.tr/en/accreditation/accreditation-certificate/search/59efe31c-e568-456a-95d8-54d82b6a5a70

Product Group	Module/Annex of the Regulation
Equipment providing foot and leg protection Equipment providing foot, leg and anti-slip protection	Module B – EU Type-examination (Annex V)
Equipment providing foot and leg protection Equipment providing foot, leg and anti-slip protection Protective equipment against electric shock	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing foot and leg protection Equipment providing foot, leg and anti-slip protection Specialized areas of competence: Fireman suits	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing foot and leg protection Equipment providing foot, leg and anti-slip protection Protective equipment against chemical agents	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing head protection	Module B – EU Type-examination (Annex V)
Equipment providing head protection Equipment providing protection against heat [heat<100°C], [heat>100°C and fire)	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing head protection Protective equipment against electric shock	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing head protection Specialized areas of competence: Fireman suits	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing hand and arm protection	Module B – EU Type-examination (Annex V)
Equipment providing hand and arm protection Equipment providing protection against heat [heat<100°C], [heat>100°C and fire	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing hand and arm protection Protective equipment against mechanical risks	Module B – EU Type-examination (Annex V)
Equipment providing hand and arm protection Protective Equipment against harmful biological agents Protective Equipment against substances and mixtures which are hazardous to health Equipment providing hand and arm protection against chemical agents	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing hand and arm protection Equipment providing protection against cold [cold >-50°C ]	Module B – EU Type-examination (Annex V)
Equipment providing hand and arm protection Specialized areas of competence: Fireman suits	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing hand and arm protection Specialized areas of competence: Protective clothing for use in welding and allied processes	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing hand and arm protection Protective Equipment against hand-held chain-saws	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing hand and arm protection Protective Clothing Against Static Electricity	Module B – EU Type-examination (Annex V)
Equipment providing hand and arm protection Protective equipment against electric shock	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII) )
Equipment providing general body protection (clothing)	Module B – EU Type-examination (Annex V)
Equipment providing general body protection (clothing) Specialized areas of competence: Protective Clothing Against Static Electricity	Module B – EU Type-examination (Annex V)
Equipment providing general body protection (clothing) Specialized areas of competence: High Visibility Clothing	Module B – EU Type-examination (Annex V)
Equipment providing general body protection (clothing) Specialized areas of competence: Protective clothing for use in welding and allied processes	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing general body protection (clothing) Equipment providing protection against heat [heat<100°C], [heat>100°C and fire and flame]	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing general body protection (clothing) Protective equipment against electric shock	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing general body protection (clothing) Equipment providing protection against extreme cold [<-50°C] Equipment providing protection against cold [cold >-50°C ] [extreme cold <-50°C ]	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing general body protection (clothing) Protective Equipment against hand-held chain-saws	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing general body protection (clothing) Specialized areas of competence: Fireman suits	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing general body protection (clothing) Protective Equipment against substances and mixtures which are hazardous to health	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing general body protection (clothing) Protective Equipment Against Risks Arising From Sports Activities	Module B – EU Type-examination (Annex V)
Equipment providing general body protection (clothing) Protective equipment against chemical agents	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing general body protection (clothing) Protective Equipment against harmful biological agents	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing respiratory system protection	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Equipment providing eye and face protection	Module B – EU Type-examination (Annex V)
Equipment providing eye and face protection Specialized areas of competence: Protective clothing for use in welding and allied processes	Module B – EU Type-examination (Annex V)
Equipment providing eye and face protection Specialized areas of competence: Protective clothing for motorcycle riders	Module B – EU Type-examination (Annex V)
Equipment providing eye and face protection Protective Equipment Against Risks Arising From Sports Activitie	Module B – EU Type-examination (Annex V)
Protective Equipment against harmful noise	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Protective equipment against drowning	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)
Protective Equipment against falls from heights	Module B – EU Type-examination (Annex V) Module C2 – Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals (Annex VII) Module D – Conformity to Type Based on Quality Assurance of The Production Process (Annex VIII)

For the application form click here

 

For detailed information, you can contact us at info@szutest.com.tr or +90 216 469 4666.

Article 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR), last amended by Regulation (EU) 2023/607, states that devices which continue to comply with the MDD may be placed on the market or put into service until 31 December 2027 or 31 December 2028, as applicable, provided the conditions set out in Article 120(3c) MDR are fulfilled.
As you know, these devices are called ‘legacy devices’ and in line with MDCG Guidance Document 2021-25, ‘legacy devices’ should be understood as devices, which, in accordance with the MDR’s transitional provisions, are placed on the market after the MDR’s date of application (i.e. 26 May 2021) if certain conditions are fulfilled.
Those devices can be:
– devices which are class I devices under Directive 93/42/EEC (MDD), for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body;
– devices covered by a valid EC certificate issued in accordance with the MDD prior to 26 May 2021.
The conditions are set out in Article 120(3c) MDR and include, among others, that legacy devices must continue to comply with the MDD, as applicable, and that there are no significant changes in the design or intended purpose of the device. Therefore, it is important for manufacturers and notified bodies to have a clear understanding as to what changes to design or intended purpose would be considered ‘significant’.
It is essential for legacy devices that their certificates remain valid following changes that are not significant with regard to design or intended purpose and that the required appropriate surveillance is carried out.

Scope
MDCG 2020-3 Rev1 is intended to provide clarification on the concept of ‘significant changes in the design and intended purpose’ under Article 120(3c), point (b) MDR. It concerns manufacturers of legacy devices.
This guidance document does not elaborate on the process for manufacturers’ submission and notified bodies’ assessment of changes to the approved design or substantial changes to the approved quality system or the product-range covered.

Changes to Directive Certificates
It is important to highlight that no issuing of new certificates is allowed under Article 120(3c), point (b) MDR. This does not mean that notified bodies are not allowed to e.g. suspend, re-insate, restrict or withdraw such certificates. Such activities should be communicated as written decisions/statements. Moreover, notified bodies should document corrections or additions to existing certificates resulting from changes that are not significant changes to design or intended purpose (e.g. administrative changes).
The implementation of such a change would prevent the manufacturer from placing the device on the market under the MDD in accordance with that provision. If the manufacturer wish to place such a changed device on the market, they may do so under the MDR.

Assessment whether changes are ‘significant changes in the design or intended purpose’ in accordance with Article 120(3c), point (b) MDR
In order to benefit from the transition periods provided by Article 120(3) MDR, legacy devices may not undergo any significant change in the design or intended purpose after the date of application of the MDR, i.e. 26 May 2021.
A significant change in the design or intended purpose consist of two cumulative elements:
• there is a change in the design or intended purpose, and
• the change is significant.
That means that changes that do not concern the design or intended purpose are out of scope of Article 120(3) MDR. Equally, changes that concern the design or intended purpose only fall under Article 120(3) MDR if they are considered ‘significant’. Changes in order to comply with other Union legislation are also out of scope even if they relate to changes in the design, only if the risk/benefit ratio of the device is not negatively affected.
The manufacturer is responsible for providing evidence and justification that a change does not affect the design or intended purpose, or, in case the change affects design or intended purpose of the device, that it is non-significant, which should be assessed case-by-case. The outcome of the assessment should be documented and made available to a competent authority when requested.

If a change is not a significant change in design or intended purpose,
– the implementation of such a change is allowed during the transitional period without the need for certification under the MDR. In such cases, the manufacturer is required to comply with the documentation requirements of the MDD. The updated technical documentation must allow assessment of the conformity of the product with the applicable requirements.

Additional considerations for devices covered by a certificate issued by SZUTEST
In line with the agreed arrangements for notification of changes between the manufacturer and the notified body according to the MDD (e.g. contractual relationships, approved procedures), changes and their implementation are to be verified by the notified body as part of the surveillance activities, or following a manufacturer’s submission for prior approval.
The outcome of this verification will determine whether a certificate in accordance with the MDD remains valid according to Article 120 MDR. In case of doubt as to whether a given change, which concerns the intended purpose or the design is significant, manufacturers should ask SZUTEST.
The certificate should not be amended. SZUTEST may confirm in FR.MED.57 Change Assessment Form and FR.MED.171 Certificate Info Ammendment Form after having reviewed the manufacturer’s description of the (proposed) change, that the implementation of the change does not represent a significant change in design or intended purpose under Article 120(3c), point (b) MDR and that the related MDD certificate remains valid until the end of the transition period.
Where the conformity assessment procedure under the MDD for a given legacy device requires the quality management system (QMS) of the manufacturer to be approved by SZUTEST, the manufacturer must observe that the conditions for which the certificate was granted are maintained. In any case, changes to the QMS continue to be subject to the agreed notification procedure between manufacturer and SZUTEST.

Changes not concerning the design or intended purpose
Changes concerning the manufacturer’s organisation (administrative changes) or changes concerning the manufacturing process should generally not be considered changes in the design or intended purpose within the meaning of Article 120(3c), point (b) MDR, even if they need to be reflected in the information to be supplied with the device (e.g. label or instructions for use). This includes for example:
• changes of the manufacturer’s name, address or legal form, including a merger or acquisition involving the manufacturer;
• changes in relation to the authorised representative relocation or addition of new manufacturing sites, including when it affects subcontractors or suppliers;
• changing the supplier of a material, substance or component, provided the specifications of the new material, substance or component do not change;
• adding or replacing a new material number for logistic reasons without changing the material;
• new process validation as part of manufacturing improvements or scale-up of manufacturing.
Changes of the QMS, such as changes in the monitoring and control of production and operations environment, generally do not impact the design or intended purpose either, provided that the conditions for which the conformity assessment certification was granted are maintained. In any case, changes continue to be subject to the agreed notification procedure between manufacturer and SZUTEST.

Changes in the design or intended purpose
Design and intended purpose
As legacy devices need to be in compliance with MDD, the benchmark for determining their design and intended purpose, as well as any possible change, should be the MDD respectively. While the MDD do not define the “design” of a device, the “intended purpose” means “the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials” (Article 1(2) letter (g) MDD).

Significance of changes
To facilitate a harmonised judgement of the significance of a change, MDCG 2020-3 Rev 1 provides several flowcharts. The assessment of a proposed change using the main flowchart and any of the applicable sub-charts is intended to assist manufacturers, notified bodies and market surveillance authorities in deciding whether or not a change of the design or intended purpose of the device is to be considered significant under Article 120(3c), point (b) MDR.
A change is considered a non-significant change of design or intended purpose per Article 120(3c) point (b) MDR if the answer to every question in a sub-chart leads to “non-significant change” also when returning to the main chart. On the contrary, if any sub-chart delivers the result “significant change”, the change being assessed is a “significant change in design or intended purpose” according to the Article 120(3c), point (b) MDR.
General considerations
As a rule, the following changes in design and/or intended purpose should be regarded as “nonsignificant”:
• changes related to corrective actions assessed and accepted by the competent authority of the Member State in which the manufacturer or its authorised representative has its registered place of business (see also Q&A 17 of the CAMD’s FAQ – MDR Transitional provisions20) regarding design changes – the same approach should apply also to changes related to the intended purpose;
• correction of spelling mistakes or merely editorial changes of the information to be supplied with the device (e.g. label or instructions for use);
• updates of the information to be supplied with the device (e.g. label, instructions for use or implant card) if they are required by EU legislation other than the MDR (e.g. CLP Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures read in conjunction with Annex I, section 7.5 MDD), are mere clarifications and do not adversely affect the devices’ safety and performance in relation to existing or new risks;
• clarifications of intended purpose, population, clinical application in the information to be supplied with the device in line with the original certification.

Changes in the intended purpose
– Chart A
Regarding changes of the intended purpose the following principles should apply (see chart A):
Non-significant change:
• Limitation of the intended purpose (see Q&A 17.3 of the CAMD’s FAQ – MDR Transitional provisions), such as:
 restriction or deletion of certain indications;
 restriction or deletion of certain applications, e.g. anatomical site, delivery pathway or deployment method;
 restricting the target population.
Significant change:
• Extension of the intended purpose, such as:
 additional or new indications;
 additional or new clinical conditions.
• New user or patient population, such as:
 additional or new target population;
 additional or new user (e.g. change from professional use to layman use).
• New way of clinical application, such as:
 additional or new applications (different stage or severity of disease);
 additional or new anatomical site;
 new delivery pathway or deployment method.
When assessing whether the intended purpose is being changed, changes in the label or instructions for use, as well as promotional materials, that are linked to the use for which a device is intended (e.g. limitations, warnings) should be considered.
Changes in the design
– Charts B to E
Changes concerning software, substances or materials, or sterilisation also concern the design of the device. Specific flowcharts (C, D, E) are intended to assist in assessing whether changes in those areas should be considered significant changes in the design.
Regarding changes of the design the following principles should apply (see chart B): Note: Change of a software shall be primarily evaluated per chart C. However, there may be cases where a major change of a software may be considered a change in built-in control mechanism or device’s operating principles and therefore are evaluated according to chart B.
Non-significant change:
• change of the design that does not alter:
 the built-in control mechanism,
 the device’s operating principle,
 the change of the source of energy, or
 the alarms systems and which does not adversely affect the safety, performance or usability and negatively affect the risk/benefit ratio of the device.
Examples:
Change in Specification/Labelling:
• change within the currently certified range (more narrow or detailed information), new article inside certified worst case or accepted bracket validations such as: new screw variant within current range of lengths and diameter; new catheter variant, with length and diameter within current range and worst case in sterilisation performance; new stent lengths which are intermediate between the previously certified stent lengths.
• change of colour of an assembly or device;
• change to the grip of a steerable ablation catheter to provide improved ergonomic comfort for the healthcare professional or aesthetic presentation of the device without changing the functionality;
• change to device housing that are minor reinforcement or attachments (handles/extra handles) or changes to supporting parts (for reduction of vibration);
• change to design for an easier operation, such as change to the thumb rest of injection syringe, change to lids or change to the mechanism of loading substances;
• change/modification of a connector to reduce misconnection and thereby improve safety of use;
• modification of a part (e.g. a connector) to adhere to a new or revised standard;
• removal of accessories (e.g. torque device) from a system (which is certified as a device) that are otherwise clinically readily available;
• formatting an existing IFU content into a newly created IFU, including reorganization of information; • editorial labelling improvements to warnings and precautions to better communicate and clarify critical information to the end user;
• adding to an existing IFU a new list of accessories including new versions of an accessory assigned to the device;
• change of label or packaging material of a non-sterile device e.g. a change in packaging from one variant of polyethylene to another due to supplier rationalization or cost saving measures;
• change to primary package size within previously validated range and previously validated sterilisation parameters;
• changes to outer packaging (e.g. size, material, layout) that do not adversely affect the stability, sterility or microbiological state of the device;
• extension of temperature or humidity range limitations for operation or storage;
• changes in reprocessing instructions, including increase of the number of allowed reprocessing cycles of a re-usable device in the related labelling, if achieved without changing the device design but provision of appropriate testing.
Note: These examples are valid only provided that the risk/benefit ratio of the device is not negatively affected.
Change of a component of a device (in particular electronics):
• change of a semiconductor/electronic component/electronic assembly, e.g. due to obsolescence;
• replacement of a semiconductor/electronic component/electronic assembly with the same specifications.
• replacement of a semiconductor/electronic component/electronic assembly with the same function, and requiring changes such as: re-layout of the printed circuit board (e.g. if not drop-in compatible); installation of a new firmware of software driver to operate the new semiconductor; adjustments of the software operating the device to accommodate the new semiconductor to operate as intended; re-arrangement of interfaces.
• addition of a coating on a non-contacting patient printed circuit board assembly (PCBA) to improve electrical current insulation;
• replacement of alarm signal generation components, e.g. LEDs, speakers;
• change of size or geometrical shape of operation/alarm buttons;
• change of the audible alarm mode by an additional red light.
Note: These examples are valid only provided that the risk/benefit ratio of the device is not negatively affected.

Change to the source of energy:
• change of a battery type, e.g. from AA to 6LR61;
• change of battery chemistry, e.g. from Alkaline to Lithium Manganese Dioxide or from lead acid batteries to lithium iron phosphate (LiFePo) batteries;
• change from a battery to a rechargeable accumulator, if recharging takes place outside of the device;
• change of battery charger or supply cords (under same specification).
Note: These examples are valid only provided that the risk/benefit ratio of the device is not negatively affected.
Significant change:
• change of the design that alter:
 the built-in control mechanism,
 the device’s operating principle,
 the change of the source of energy, or
 the alarms systems.
Examples:
• change from analogue to digital control;
• change from manual to software driven device;
• change to measuring function, wavelength or light emission;
• replacement of PCB with new feature or change of control circuits;
• change from energy source battery or accumulator to net-power operation of the device or vice versa; or from LED (Light-Emitting Diode ) to U.V rays;
• reduction of battery operating time;
• change of an advisor for the Insulin-bolus-volume in an Insulin pump;
• silencing/removing/adding of an alarm system or handling of alarm situation.

Changes that may adversely affect the safety or performance and negatively affect the risk/benefit ratio of the device, even if they do not alter the built-in control mechanism, the device’s operating principle, the change of the source of energy or the alarm systems.
Examples:
• change to device dimensions or design characteristics outside of current specifications, such as: new stent lengths which are outside of the range of the previously certified stent lengths; addition of two or more electrodes, or a new anchoring mechanism on an implantable pacing lead; reduction in size of the wire diameter to reduce the overall pacing lead diameter;
• widening of specification limits on critical component/parameter;
• new sensors with different working principle (e.g. air bubble detector with ultrasound vs light sensor; alarm noise to light);
• change to mechanisms for preventing reflux of substances;
• removal of a design and development input.
Software changes
– Chart C
Regarding software changes the following principles should apply (see chart C):
Non-significant change:
Examples:
• correction of an error which brings the device back to its original specification (bug fix);
• performance improvements intended to reduce latency;
• security update (e.g. cyber-security enhancements, longevity calculations);
• updates or upgrades of standard third-party operating systems, e.g. Microsoft Windows, iOS, Android;
• appearance of the user interface (e.g. new languages, layouts or graphics) provided that the changes do neither negatively affect the usability nor add new functions;
• changes to enhance the user interface without changes in performance (e.g. software change to allow the healthcare professional to select and/or change the preexisting units of measure on a blood oxygen monitor);
• improvement to operating efficiencies (e.g. allow the queuing of multiple criteria without alteration to performance, safety or interpretation of data);
• new non-medical features, such as: software changes only introducing non-therapeutic and/or non-diagnostic features (e.g. printing, improved image clarity, reporting format, additional languages, barcode reader); change of the software manufacturer’s graphical charter (logo, colours, fonts); change including algorithm change impacting the control of the device without alteration of diagnosis or treatment; software change that disables a feature that does not interact with other features; displaying data on the screen which were already present in the device and part of the original conformity assessment.
Note: These examples are valid only provided that the risk/benefit ratio of the device is not negatively affected.
Significant change:
Examples:
• new or major change of operating system or any component (beyond minor changes) (e.g. Linux to Windows or iOS or Android) or new version of an operating system Windows 10 to Windows 11) if modification to the device software is required;
• new or major modification of architecture;
• change of an algorithm which impact the operating principles or impact the control of the device and may alter the diagnosis or therapy delivered;
• required user input replaced by closed loop algorithm;
• new user interface, such as: presentation of medical data in a new format or by a new dimension or measuring unit; keyboard input to touchscreen; keyboard to wireless remote control; software changes that impacts the way data is read or interpreted by the user, such that the treatment of the patient may be altered when compared to previous version of software;
• new medical feature or functionality that may change the diagnosis or the therapy delivered to the patient;
• new channel of interoperability (e.g. software changes that allow for wireless communication with compatible -continuous- blood glucose monitors).
Changes related to a substance or material
– Chart D
Regarding changes of substances or materials the following principles should apply (see MDCG 2020-3 Chart D):
Non-significant change:
• new or additional supplier/producer of a material within the defined specifications;
• substitution of a chemical substance in order to comply with other applicable laws and regulations e.g. REACH Regulation (EC) No 1907/2006;
• replacing a substance or material, unless considered a significant change as listed below. Examples: • update to material grade (e.g. additives in Loctite adhesive) with no change to specification;
• change in supplier that extrudes the polymer tubing with no change in device specifications;
• replacing a material of a sterile device’s packaging that has no function in maintaining the sterile barrier or packaging integrity;
• change in a material which serves solely as a processing aid which is not available on the finally cleaned device and therefore considered a manufacturing but not a design change;
• addition of an antioxidant to the drug coating of a combination product that reduces the degradation of the drug during production but does not alter its pharmaceutical properties or release kinetics.
Note: These examples are valid only provided that the risk/benefit ratio of the device is not negatively affected.
Significant change:
• change to a material or substance which is part of an implant and intended for direct or indirect contact with patient tissue or fluid for more than 30 days, or is part of a surgically invasive device which is absorbed;
• addition or change of a material of human/animal origin (e.g. collagen produced from skins by collagen produced from bones);
• change to a material containing a medicinal substance (i.e. excipient or carrier material with influence on the delivery of the medicinal substance), or to the medicinal substance itself;
• change from a material with a low toxicological or biological risk to a material with a higher one;
• new or changed substance or material that adversely affects the safety or performance of the device and therefore negatively affects the risk/benefit ratio of the device.
Changes related to sterilisation
– Chart E
Regarding changes related to the sterilisation method or related to the design or the packaging with impact on the sterile condition of the device, the following principles should apply (see chart E):
Non-significant change:
• change of the sterilisation cycle parameters;
• extension of the shelf life validated by protocols approved by the notified body;
• new sterilisation vendor or chamber;
• change from single sterile to double sterile packaging.
Note: These examples are valid only provided that there is not impact to sterility assurance level or sterilisation residuals.
Significant change:
• change of the terminal sterilisation method (e.g. ETO to Gamma);
• change from biological indicator to parametric release;
• changing a device from labelled “non-sterile” to labelled “sterile”;
• change (e.g. of the device) which adversely affects the sterility assurance level;
• change in packaging design which affects sterility, stability or microbiological state of the device, including seal integrity;
• extension of the (labelled) shelf life which is not validated against protocols approved by the notified body.
• changes to storage or transportation conditions which could adversely affect the sterility or stability.

For application of Flow Charts, please see MDCG 2020-3 Flow ChartsA, B, C, D and E.

We hope that the information provided above will be useful in your change evaluation efforts.

SZUTEST UYGUNLUK DEĞERLENDİRME A.Ş.
Adres: Tatlısu Mahallesi, Akif İnan Sk. No:1, 34774 Ümraniye/İstanbul
Tel: +90 216 469 46 66 (pbx)
Fax: +90 216 469 46 67
Email: info@szutest.com.tr

 In line with Article 27 of the (EU) 2017/745 Medical Device Regulation (MDR), manufacturers for all medical devices, except for custom-made devices to be certified under MDR;

1. a) the creation of a UDI, including:

1) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device

2) a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices

28. b) placing of the UDI on the label of the device or on its packaging and before a device is placed on the market the manufacturer shall ensure that the information referred to in Part B of Annex VI of the device in question are correctly submitted and transferred to the UDI database referred to in Article 28.

• UDI carriers are placed on the label of the device and on all upper levels of the packaging. Upper levels of packaging do not include shipping containers.
• The UDI shall be used for reporting serious incidents and field  safety corrective actions in  accordance with Article 87
• The Basic UDI-DI, as defined in Part C of Annex VI, of the device shall appear on the EU declaration of conformity referred to in Article 19.
• Manufacturers shall keep the list of all assigned UDIs up to date as part of the technical documentation referred to in Annex II.

The guidance document “MDCG 2021-25” has been published for legacy devices manufactured within the scope of the Medical Device Regulation (93/42/EEC) and to be placed on the market after 26.05.2021.

According to this guide, it is seen that MDR “Article 27 Single Device Identification System” is not applicable for legacy devices, while “MDR Article 29 Devices Registration” provision is applicable.

In this context, the guidance document published on “Registration of Legacy Devices in MDCG 2019-5 EUDAMED” provides information on how to EUDAMED registration of legacy devices that do not have Basic UDI-DI according to MDR article 27.

In line with the MDR and guidance documents, there is no obligation to have UDI on the legacy devices themselves, on their labels and on their packaging.

In accordance with Regulation (EU) 2023/607 dated March 20, 2023, changes regarding the dates on which medical devices with a certificate within the scope of the 93/42/EC Medical Device Directive can be placed on the market or put into service have entered into force.

In accordance to the (EU) 2017/745 Medical Device Regulation (MDR) Article 120 “Temporary Provisions”, Regulation (EU) 2020/561 and Regulation (EU) 2023/607, certificates issued in accordance with 93/42/EEC Directive from 25 May 2017 by SZUTEST Conformity Assessment Inc. that still were valid on 26 May 2021 and that have not been withdrawn afterwards shall remain valid after the end of the period indicated on the certificate until the dates set out in MDR Article 120(3a) for the relevant risk class of the devices.

Certificates issued by SZUTEST Conformity Assessment Inc. in accordance with 93/42/EEC Directive from 25 May 2017 that were still valid on 26 May 2021 and that have expired before 20 March 2023 shall be considered to be valid until the dates set out in paragraph 3a of this Article only if one of the following conditions is fulfilled:

(a) before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII to this Regulation for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device;

(b) a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59(1) of this Regulation or has required the manufacturer, in accordance with Article 97(1) of this Regulation, to carry out the applicable conformity assessment procedure.

In the light of the information given above, the certificate validity dates have been extended as stated below in accordance with Article 120 (3) of the Regulation (EU) 2017/745.

(3a) 31 December 2027, for class III devices and for class IIb implantable devices, except sutures, ataples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;

(3b) 31 December 2028, for class IIb devices other than those covered by point (a) of this paragraph, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.

Devices referred to in paragraphs 3a and 3b of this Article may be placed on the market or put into service until the dates referred to in those paragraphs only if the following conditions are met:

(a) those devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable;

(b) there are no significant changes in the design and intended purpose;

(c) the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;

(d) no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9);

(e) no later than 26 May 2024, the manufacturer, or an authorised representative, has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment in respect of a device referred to in paragraphs 3a and 3b of this Article or in respect of a device intended to substitute that device, and no later than 26 September 2024, the notified body and the manufacturer have signed a written agreement of Annex VII.

Class I devices that do not require a Notified Body’s assessment of the conformity assessment procedure; devices for which the declaration of conformity was issued prior to 26 May 2021 and for which the conformity assessment procedure pursuant to MDR requires the involvement of a Notified Body, may be placed on the market or put into service until 31 December 2028.

For the purpose of Article 120(3a) MDR, which provides for the new transitional periods depending on the device’s risk class, the classification rules laid down in Annex VIII to the MDR apply. In certain cases, where the classification rules of the MDR result in a different risk class, the device’s risk class indicated on the certificate may differ from the risk class that determines the end date of the transitional period.

However, where during the transitional period the risk class of a device is needed to determine applicable MDR requirements (e.g. in relation to PSUR), the class of the device is the one established in accordance with the MDD classification rules.

SZUTEST Conformity Assessment Inc. shall apply the requirements of the MDR on post-market surveillance, market surveillance and audit, vigilance, registration of economic operators and devices in place of the requirements corresponding to the Medical Device Directive 93/42/EEC to these devices.

Until 26 September 2024, unless the manufacturer agrees with a notified body assigned under the MDR that it will carry out the surveillance assessment, SZUTEST Conformity Assessment Inc. shall continue to be responsible for the necessary surveillance audit for all applicable requirements of 93/42/EEC provided that there is no significant change in the design and the intended use of the devices it has certified. This assessment shall also cover unannounced audits.

Not later than 26 September 2024, the notified body that has signed the written agreement referred to in subparagraph (e) of MDR Article 120 (3c) shall be responsible for the surveillance of devices covered by the written agreement, if specified in the agreement. Where the written agreement covers a device intended to replace a device with a certificate issued under Directive 93/42/EEC, surveillance is carried out according to the device to be replaced (under the existing certificate).

Surveillance assessments upon the request of the certified manufacturer; arrangements regarding the transfer from SZUTEST Conformity Assessment Inc to the notified body appointed under the MDR; where applicable; the manufacturer is clearly defined in an agreement between the notified body appointed under the MDR and SZUTEST Conformity Assessment Inc. The notified body appointed under the MDR is not responsible for the conformity assessment activities carried out by SZUTEST Conformity Assessment Inc.

Manufacturers certified by SZUTEST Conformity Assessment Inc. shall submit their applications for the transfer of surveillance assessments to the SZUTEST Conformity Assessment Inc. Sales Unit with the FR.MED.201 Application Form for Transferring Surveillance Assessments in order to benefit from the time extension for the transition period.

The transition period to EU 2017/745 Regulation has ended as of 26 May 2021. From this date, manufacturers shall need to certify their products under the EU 2017/745 Regulation if they request CE certification for the first time or if they want to make significant changes in the design or intended use of CE certified products. For the above-mentioned products, the MDR requirements shall be fully implemented from this date.

Within the scope of 93/42/EEC Directive, the certificates of the manufacturers who have CE certificate before 26 May 2021 shall be valid until 26 May 2024, while the certified products shall be available on the market until 26 May 2025. For these products, post-market surveillance, market surveillance, vigilance activities, registration of economic actors and devices shall be carried out in accordance with the EU 2017/745 Regulation.

SZUTEST shall not carry out initial certification, re-certification or significant change assessment activities within the scope of 93/42/EEC Directive as of 26 May 2021. It will continue to carry out surveillance audit, unannounced audit, follow-up audit, non-significant change assessment activities for products certified before this date.

SZUTEST shall assess whether the manufacturer’s post-market surveillance system is suitable for actively and systematically collecting, recording, analyzing and drawing the necessary conclusions and determining data on the quality, performance and safety of a device throughout its entire lifecycle, implementing preventive and corrective actions and will evaluate its monitoring according to the (EU) 2017/745 Regulation.

In this context, FR.MED.63 Medical Devices General Terms has been updated and published on our website.

You can access the general information text regarding the change assessment applications within the scope of the 93/42/EC Medical Device Regulation on our website.

In order for competent authorities, Notified Bodies and manufacturers to make a smooth transition, the provisions for the transition period are explained in Article 120 of the EU 2017/745 Regulation.

The “Medical Device Regulation” prepared completely in line with the “Regulation (EU) 2017/745 on Medical Devices” was published in the Official Gazette on 02.06.2021 and entered into force in a way that is valid as of 26/05/2021 by the Turkish Republic Ministry of Health.

As known the new MDR (EU) 2017/745 will come into force on  2021.05.26. Szutest has defined the deadline for Certification, re-certification and scope extension applications for 93/42/EEC as 2020 October 31. After this date applications will not processsed.

Medical devices general terms is updated by providing MDR (EU)2017/745 transition requirements.