Announcement on CE Conformity Assessment Activities within the Scope of 93/42/ EEC Medical Device Directive!

Due to the COVID-19 outbreak and the associated public health crisis, the implementation date of the (EU) 2017/745 Medical Device Regulation (MDR) was changed to 26 May 2021 by the (EU) 2020/561 Regulation dated 24.04.2020. After this date, CE Certification, Recertification and Scope Extension activities shall not be carried out within the scope of 93/42/EEC Medical Device Directive.

From May 26, 2021, manufacturers that have CE Certificate under 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, or in case of certification requests, they can apply to the notified bodies designated under the (EU) 2017/745 Medical Device Regulation.

Within the scope of 93/42/EEC Medical Device Directive, the deadline for application of certification, recertification, scope extension, significant change in the design or intended use has been determined by SZUTEST as October 31, 2020. Applications made after this date will not be processed.

Certificates issued as of 25/05/2017 within the scope of 93/42/EEC Medical Device Directive; It will remain valid until the end of the period specified on the certificate and not exceeding 5 years from its issuance. However, these certificates will be invalid as of 27/5/2024.

For medical devices that will have a valid certificate after May 26, 2021 within the scope of 93/42/EEC Medical Devices Regulation, the relevant provisions of the (EU) 2017/745 Medical Devices Regulation for post-market surveillance, market surveillance, vigilance and registration of economic actors and devices shall be applied after May 26, 2021. For this reason, manufacturers should start their preparations in line with the requirements of post-market surveillance, vigilance and relevant registration regarding to Medical Device Regulation.