Announcement Regarding 93/42/EEC Directive and EU 2017/745 MDR Requirements on CE Conformity Assessment Activities!

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.