Progress has been made on several fronts in relation to the roll-out of regulations and guidance for the Medical Device Regulation (MDR, 2017/745) in recent weeks.
Firstly, the 16th and 17th MDR Notified Bodies have been named on the NANDO database, these being DQS Medizinprodukte GmbH, Germany, making it the sixth Notified Body to be designated from that country, and 3EC International a.s. from Slovakia, the first designated from there. DQS has Notified Body number 0297, and the scope of its designation can be found here, while 3EC has Notified Body number 2265, and its scope can be found here.
Secondly, in a new guidance document, MDCG 2020-14, the European Commission’s Medical Device Coordination Group (MDCG) details how Notified Bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the MDR. While MDSAP audit reports cannot be used to obviate the need for annual surveillance audits required under MDR, MDCG says the reports can be used to inform the scope and focus of surveillance audits performed. “It is important to stress that the MDR/IVDR remain applicable in their entirety. The use of MDSAP audit reports within the EU legislative framework is possible only where the MDSAP audit covers similar or equivalent MDR/IVDR requirements,” MDCG writes.
The MDCG has also published MDCG 2020-15 on the use of the Eudamed registration module and the Single Registration Number (SRN), as it plans to open up the Eudamed actor registration module for voluntary use from 1 December 2020, allowing users to receive their SRNs from the applicable Competent Authority. The SRNs will identify manufacturers, authorized representatives and importers in the database. The registration module “forms a prerequisite for the use of the other Eudamed modules and facilitates a secure way of accessing Eudamed” MDCG says, adding that it “strongly encourage the use of the actor registration module by all relevant actors on their territories, including the use of the single registration number by actors as stipulated in the MDR (e.g. indicating the SRN on certificates)”.
The Commission has published a Q&A document on unique device identification (UDI) requirements under the MDR/IVDR, covering the basics, from ‘What is UDI’ to ‘Legacy device UDI requirements’.
The Commission has also published a new regulation, ‘Implementing Regulation (EU) 2020/1207‘, establishing common specifications for the reprocessing of single-use medical devices under the MDR. Under the MDR, single-use devices may be reprocessed where permitted by national law. Member states may also determine what rules they will apply to single-use devices reprocessed and used within a health institution, so long as the reprocessing is performed in accordance with the common specifications laid out in the regulation. The regulation includes several changes from the draft version released for comment in July 2019.