Manufacturers of medical devices are eagerly waiting for more guidance on the implementation of the MDR. MDCG has now issued a useful guidance on the Summary of Safety and Clinical Performance (SSCP) and on the handling of MDD certificates for legacy devices.
The Medical Device Coordination Group (MDCG) issued a new guidance document on certificates that have been issued under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and the Medical Devices Directive 93/42/EEC (MDD).
Article 120 of Regulation (EU) 2017/745 on medical devices (MDR) generally says that products that have been manufactured in accordance with a valid MDD certificate beyond May 2020, may still be placed on the market until the corresponding certificate expires. However, the issuing Notified Body still remains responsible for the surveillance activities as a precondition.
The MDCG document now clarifies that the contract between the manufacturer and the Notified Body must provide for the surveillance responsibilities for the certificate (diesen Satz als Pullquote). Furthermore, the document says that that “Authorities responsible for notified bodies have the right to and do monitor those notified body’s activities to the extent appropriate and necessary.”
Furthermore, MDCG published a guidance document on the SSCP. According to article 32 of the MDR, manufacturers of implantables and class III devices must set up the SSCP and provide it to the Notified Body. The Notified Body will then upload the document to EUDAMED.
The guidance specifies among others, which contents should be included and provides details about the validation procedure. It also reflects a sample template.
Should you have any specific questions or require the full document for your reference, please don’t hesitate to get in touch.
Sources: MDCG guidance documents, MDR