Regulation (EU) 2023/607 MDR transitional arrangements for Class III and Class IIb, implantable devices

This section is about: Regulation (EU) 2023/607 Regulation (EU) 2023/607 on MDR transitional arrangements allows for manufacturers of devices that were certified under the ‘old’ Directives to remain certified as such for some years to come, while they wait until they become certified under the MDR. In general, this will require the manufacturer to prepare … Read more

Regulation 2023/607 MDR transitional arrangements for Class IIa and Class IIb, non-implantable devices

This section is about: Regulation (EU) 2023/607 Regulation (EU) 2023/607 on MDR transitional arrangements allows for manufacturers of devices that were certified under the ‘old’ Directives to remain certified as such for some years to come, while they wait until they become certified under the MDR. In general, this will require the manufacturer to prepare … Read more

PRRC scenario

PRRC scenario, as posted on LinkedIn on 8 February 2023 According to MDCG Guidance 2021-25 on legacy medical devices, the PRRC is not required for legacy devices. With that in mind, a freshly appointed PRRC had a fairly easy job; the company was not MDR certified yet. With the current proposal of the European Commission … Read more