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

When is a Person Responsible for Regulatory Compliance (PRRC) required?

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.

Where will I find published common specifications, delegated acts and implementing acts?

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

For class I devices, when do we need to comply with MDR?

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.

For an IVDR, class general, when do we need to comply with IVDR?

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

What are the new requirements for importers and distributors?

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.

Where can I find information on what notified bodies that have been designated?

They will be listed in the NANDO database on the European Commission webpage. http://ec.europa.eu/growth/tools-databases/nando/

If we have a valid certificate according to MDD, how will our QMS be affected and when will it need to be updated?

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.

What parts will be regulated on a national level?

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