Due to lack of Notified Body (NB) capacity, lack of access to NB for SMEs, supply chain disruptions (Covid-19, Ukraine war,…),…the MDR implementation is creating bottlenecks in product certification.
A new regulation ((EU) 2023/607) has been published, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
The Regulation enters into force 20 March 2023 and is directly applicable in all Member States.
The following amendments are made:
Regulation (EU) 2017/745: Article 120, Article 122 and Article 123
Regulation (EU) 2017/746: Article 110 and Article 112.
The key amendments made revolve around an extension to the validity period of MDD and AIMDD certificates and the transition period to the EU MDR.
On the website of the Commission, a Q&A on practical aspects related to this Regulation has been published.