After May 26, 2021, manufacturers who have CE Certificate within the scope of the 93/42/EEC Medical Device Directive may place the device on the market or put into service, provided that there is no significant change in the design and intended use of the certified device. When manufacturers want to make a significant change in the design or intended use of the certified device, they can apply for certification to notified bodies appointed under the Medical Device Regulation (EU) 2017/745.
On March 16, 2020, the Medical Device Coordination Group (MDCG) issued a document MDCG 2020-3 “Guidance on important changes for devices covered by MDD or AIMDD certificates related to the transition process under MDR Article 120”. This guidance document provides instructions on how manufacturers go about making significant changes to certified devices and on changes to a device that should be considered “a significant change in design or intended use” as per Article 120 (3) of the MDR.
Manufacturers who have CE Certificate within the scope of 93/42/EEC Medical Device Directive should adapt this guideline to quality management systems and take it into consideration when they plan to make changes to the certified device.
SZUTEST receives the manufacturer’s change notifications in writing with FR.MED.51 Change Notification Form. Where applicable, the FR.MED.01 Application Form for the change must be filled in by the manufacturer.
Within the framework of conformity assessment activities, SZUTEST shall perform all change evaluations in line with the Medical Device Directive and MDCG 2020-3 guideline document. All changes related to the organizational changes, the quality management system and the device shall be reviewed in all audits conducted within the scope of 93/42/EEC Medical Device Directive.
All producers who have a valid certificate within the scope of 93/42/EEC Medical Device Directive should review this guideline document and adapt it to their quality management systems and it should be taken into consideration in all important change notifications in the following processes.
In case of change, the assessments should be made for each device on a case-by-case basis. Flow charts have been developed to facilitate harmonized judgement on the significance of the changes.
If the manufacturer want to make a “significant change in design or intended use” pursuant to Article 120 (3) of the MDR, the application of such a change will prevent the manufacturer from continuing to place this device on the market under the 93/42/EEC Medical Device Directive. For this reason, manufacturers are not allowed to make significant changes to the design or to make significant changes to the intended use of the device. If producers are in doubt as to whether a change is significant, they should ask their notified body.
Administrative changes of manufacturers are in principle considered insignificant. This includes administrative changes such as changes to the manufacturer’s name, address or authorized representative.
It can be considered that all changes that have no effect on the design or intended use of the device are not significant according to MDR Article 120 (3). However, the manufacturer is always responsible for providing evidence that these changes do not actually affect either the design or the intended use.
Changes that are likely to affect the design or intended use of the device should be considered significant.
Furthermore, all changes not having an impact on the design or the intended purpose of the device can be regarded as not significant in the meaning of MDR Article 120(3). This is the case for example of relocation or addition of new manufacturing sites, including when it affects subcontractors or suppliers, or of certain changes of the quality management system, provided that the conditions for which the conformity assessment certification was granted are maintained. Nevertheless, such changes continue to be subject to the agreed notification procedure identified in the first paragraph of the current section. The manufacturer should always remain responsible for providing evidence that all the above-mentioned changes do indeed neither affect the design nor the intended purpose.
After assessment of the explanation of the change requested by the manufacturer with the MDD certificate issued by SZUTEST, it is confirmed in writing with the FR.MED.171 Certificate Information Change Form that the implementation of the change does not represent a significant change in the design or intended use of the certified device in accordance with MDR Article 120 (3).
In requests from the competent authorities, the manufacturer shall submit these documents obtained from the SZUTEST, numbered and together with the main certificate.
In relation to class I medical devices requiring the involvement of a notified body for the first time, manufacturers of such devices should be able to justify their decision if they consider the changes to be non-significant. The justification shall be documented and made available when requested.
In the annex of the MDCG 2020-3 Guide document, various flow charts based on NBOG 2014-3 “Guidance on Reporting Design Changes and Changes in the Quality System for Manufacturers and Notified Bodies” are presented. There is a main and 5 sub-charts within the scope of these flowcharts. There are redirections to sub-scharts (A-E) in the main chart. Changes are considered as significant changes or non-significant changes according to the answers to the questions in the main chart or sub-charts.
In particular, “Flowchart C” is specific for software. It is used in Annex VI, Section C, section 6.5 of the MDR to describe changes that are considered to be a significant change in software design.
If the change made to the device as a result of any sub-flow chart is defined as a significant change, MDR Article 120 (3) should be considered.
Questions are guided through the Main Chart as follows:
Is there any change in the device covered by 93/42/EEC Medical Device Directive?
- Chart A – Change of purpose?
- Diagram B – Change in design or performance characteristics?
- Chart C – Software change?
- Chart D – Material change?
- Chart E – Sterilization method or packaging design change that has an impact on sterilization?
Chart A (if there is a change in the purpose of use);
- Restriction in the intended use is a non-significant change.
– Expanding or changing the purpose of use,
– New user or patient population, and
– Changes in clinical use (changing the anatomical region where the device is used, changing the method of use) are important changes.
In the absence of these changes, it can be regarded that there is no significant change in the purpose of use according to MDR Article 120 (3).
Chart B (If there is a change in design or performance characteristics);
– Design changes in the main Chart within the scope of corrective actions are non-significant changes according to MDR Article 120 (3).
– If the design change requires additional clinical or usability studies to support the safety and performance of the device,
– If the new risks caused by the change require new measures or if they negatively affect existing risks,
– If there is a change in the internal control mechanism, operating principles, energy or alarm sources, it is a significant change.
In the absence of these changes, it is decided that there is no significant change in the design according to MDR Article 120 (3).
Chart C (If there is a software change);
New or major changes in the operating system or a component,
– New or changed architecture or database structure,
– If user input is required replaced by the closed loop algorithm,
– New diagnostic or therapeutic feature, new user interface or data presentation is a major change.
Minor changes are non-significant changes. Fixing a bug that does not pose a security risk (bug fixes), security updates, user interface image, expanding the user interface in a way that does not affect operating efficiency and performance are examples of minor changes that do not affect diagnosis and treatment.
If there are no major software changes mentioned above or only minor changes, it is decided that there are no significant changes in the software.
Chart D (If there is material change);
– If there is a change in materials of human or animal origin or a new material addition, it is a significant change, otherwise it is reviewed together with the Design Chart (Chart B).
– It is a significant change in materials containing medicinal products, changes that may affect the safety, effect and quality of the medicinal product itself (for example, change in the production process), otherwise it is reviewed together with the Design Chart (Chart B).
– Not material change if the changed component or material from the current supplier meets the current specifications. If these materials do not meet current specifications, they are reviewed together with the Design Chart (Chart B).
– If material or components are purchased from the new supplier to meet existing specifications, this change is reviewed with the design Chart (Chart B).
– If the material purchased from the new supplier does not meet the current specifications, it is a significant change according to MDR Article 120 (3).
Chart E (if there is a change in the sterilization method or the packaging design affecting sterilization);
– Changing the sterilization method; The important change is whether the non-sterile product is sterile or the sterilization method is changed.
– Changes in cycle parameters within the scope of the approved Quality Management System are insignificant changes.
– As specified in the relevant sterilization standards (EN ISO 11135 (Ethylene Oxide), EN ISO 11137-1 (Radiation), EN ISO 17665-1 (Moist Heat), EN ISO 13408-1 (Aseptic Process)) may affect or change the sterility safety design changes are significant changes.
– Changes that affect functionality, safety, stability and adhesion integrity in packaging design are important changes.
– Shelf life changes validated by protocols approved by the notified body are non-significant changes. Unvalidated shelf-life changes with protocols approved by the notified body are a significant change. In principle, the shelf life increase is a non-significant change. (The increase can be made based on the result of the real-time aging test performed using the method that has been previously validated and reviewed by the notified body.)
If all the questions given in the main Chart are answered “no” and the questions stated in the sub-Charts are answered “is a non-significant change”, the change is considered as a non-significant change according to the Medical Device Regulation Article 120 (3).
We hope that the information provided above will be useful in your change assessment activities.
SZUTEST CONFORMITY ASSESSMENT INC.
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Email: info@szutest.com.tr