Medical Devices – EU MDR CERTIFICATE (EU)2017/745

Services provided by SZUTEST for medical devices are as follows:

• (EU)2017/745 Conformity Assessment EU MDR Certification
• Biomechanical tests – Implant tests
• ISO 13485 Quality Management System Certification
• Cybersecurity Testing (Hardware and Software)

According to current regulation;
A medical device means any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

• Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease
• Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
• Investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state
• Control or support of conception
• Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations

and which does not achieve its principal intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The classification references in Annex VIII of the EU MDR are as follows:

• Class I devices with low risk such as external patient support products. Class I devices which are provided sterile are considered Class Is and Class I devices with measuring function are Class Im and reusable surgical instruments are class Ir.
• Class IIa, Class Iib devices with medium risk such as electro-medical devices and implants
• Class III devices with high risk such as cardiovascular catheters.

All Class Is, Im, Ir, IIa, IIb, and Class III devices require a Notified Body approval such as SZUTEST GmbH No.2975 and Medical CE Certificate. Manufacturers of these products must apply to a Notified Body. As a Notified Body for CE Certification, SZUTEST GmbH can issue device-specific CE Certificates. After getting CE Certificate for your medical device, your data will be registered to EUDAMED (EU Databank) and you will gain the right of free movement of your products within the European market.

The technical documentation contents to be included in the EU MDR Technical Documentation should be as follows:

• Product Description: Intended purpose, mode of application, components list, contents, duration of use, patient population, indications/contraindications, side effects and other descriptive information.
• Classification: The medical device manufacturer must indicate the class of the device and provide the rationale (class I, class Is, Ir, class Im, class IIa, class IIb or class III) based on the requirements in Annex VIII of (EU)2017/745
• General Safety and Performance Requirements Cheklist (GSPR): The manufacturer shall explain in detail with a checklist that the medical device is in conformity with the General Safety and Performance Requirements in Annex I and how the performance of the medical device is demonstrated. In this explanation, the related harmonised standards, test reports, related parts of the technical documentation and documents in the quality management system shall be shown as reference.
• Risk Management: The manufacturer shall perform a risk analysis of design, production and post-market processes of the medical device.
• Clinical Evaluation: A clinical evaluation shall be carried out according to MDCG and Meddev 2.7.1 guidance document and inline with the requirements of Annex XIV of (EU)2017/745 MDR Regulation. Clinical data must include data from the device itself or same or similar devices, and the clinical literature on these devices must be systematically evaluated by an experienced expert having the related scientific background.
• Validation: All parameters that can affect the safety and performance of the Medical Device and the processes that can influence these parameters shall be validated. The records of this validation shall be included in the technical documentation.

According to the current regulation, many notified bodies are designated for annexes covering quality management system assessments. The quality management system requirements that medical device manufacturers shall conform to are defined in related annexes of the regulation.
The Quality System implemented must ensure the conformity of products with the requirements of the medical devices regulation. All elements and requirements adapted to the quality management system, must be documented systematically in the form of written principles and procedures (quality programme, quality plan, quality manual and quality records).

SZUTEST is accredited by TURKAK (Turkish Accreditation Agency) for medical devices according to ISO 17021-1 and ISO 17025 standards. Our accreditation scope covers EN ISO 13485:2016 and biomechanical implant testing.

Authority for CE certification is called “notification”, not “accreditation”. SZUTEST GmbH has got notification from the German Authority ZLG and the European Commission. The European Commission issues the names and scopes of the notified bodies in “NANDO” database. You can confirm SZUTEST GmBHs notification by visiting the NANDO website

You may visit Szutest GmbH’s
Guidance documents such as MDCG, can help you understand the working principle of the EU Medical Device MDR certification system.