General safety and performance requirements (GSPR)

A vital part of MDR and IVDR

In May 2017 EU introduced two new regulations for medical devices; Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).

MDR is applicable from May 26, 2021 and IVDR from May 26, 2022.

All manufacturers and authorized representatives shall have a Person Responsible for Regulatory Compliance (PRRC) available within the organization (see below for more info).

FAQ – general for MDR/IVDR

All manufacturers and authorized representatives need to have a PRRC assigned. Requirements of qualifications for the PRRC and areas of responsibilities are listen in Article 15 of MDR and IVDR.

They will be published on the European commission webpage and by competent authorities in each country.

Date of application for Class I is 26th of May 2021, by this date a registration or certificate according to MDR must be achieved to continue to place cE-marked devices on the market. An extended transition period can be applicable for devices that are up-classified going from MDD to MDR, and where no significant changes are planned. See the second corrigendum for MDR for more details on the possibility for an extended transition period.

Class general devices under IVDD need to have a new registration or certificate under IVDR by May 2022.

New and stricter requirements for all economic operators, they will control each other and partially the conformity of the devices they are handling, as well as reporting in to Eudamed*).

Name and address of the importers shall be included in the device labeling or accompanying documentation. Article 13 and 14 is a good start for understanding these requirements on importers and distributors.

They will be listed in the NANDO database on the European Commission webpage.

The QMS for all devices (including those with a valid certificate after May 2021) need to fulfill the requirements on post market surveillance, vigilance, registration of economic operators and UDI by May 2021. Other parts of the QMS will be included in the MDR audit when applying for a MDR certificate.

Examples on sections that are regulated on a national level are language requirements and labeling, reprocessing of devices and national registration fees.

)* EUDAMED is an EU database where manufacturers shall register products, report incidents and continuously report safety information. Parts of the database will be public.

Contact me for further information
Robert Ginsberg
Office +46 8 621 01 05 or send me an mail