The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) issued new recommendations on the availability and capacity of notified bodies (NBs) and the sustainability of the grace period under the European Union’s (EU) medical device regulation (MDR).
The recommendations, detailed in a position paper released Thursday, address challenges with the ongoing lack of NBs designated under MDR and confusion regarding the regulation’s grace period.
In its assessment, COCIR says that “very little progress has been made in the implementation of the regulation” compared to its last assessment
in November 2018.
COCIR recommends limiting initial certification to a manufacturer’s quality management system and “a sample of one device per device group for class IIa and class IIb devices at initial MDR certification assessment.” On challenges specific to manufacturers of class I software products, COCIR calls for an EU-wide contingency plan for manufacturers that need a NB and allowing class I devices to use the grace period.
COCIR also suggests that certificates issued under the International Medical Device Regulators Forum’s (IMDRF) Medical Device Single Audit Program (MDSAP) could help offset the lack of NBs designated under MDR.
“There is no indication that a significant number of notified bodies will be designated in the next months,” COCIR says. The two NBs that have been designated under MDR to date—BSI UK and TÜV SÜD—are “by far not enough to accommodate the demand of medical device manufacturers.”
Other industry groups have also raised
concerns over the lack of designated NBs. Authorities have reportedly held discussions
behind closed door to have a backup plan for the in vitro
diagnostic regulation (IVDR) just in case there are not enough NBs designated under IVDR ahead of its 26 May 2022 date of application, but there have been no such discussions for MDR. Questions on MDR obligations relating to NBs were addressed
in a Q&A document released by the European Commission on Thursday.
On using the grace period under Article 120(3) of MDR, the position paper identifies approaches for clarification of the term “significant change” to device and the registration of legacy devices post-MDR.
COCIR seeks “specific guidance on significant change as reference in Article 120(3)” that “needs to acknowledge” that certificates issued under the current directive will “remain valid following changes that are unrelated to design or intended purpose of the device in question.” This recommendation builds on the Competent Authorities for Medical Devices’ January 2018 guidance
COCIR also takes issue with guidance
published by the EC in April that informed that legacy devices registered in Eudamed “will need two other unique access keys (IDs) to replace the Basic UDI-DI and UDI-DI for the sake of the workability of Eudamed.” This results in both a Eudamed device identifier (DI) and a Eudamed ID rather than the Basic UDI-DI so that the system can work and keep Eudamed’s design “as close as possible to the MDR design.” COCIR argues that this change in unique device identification (UDI) was introduced too closely to the one-year mark in the countdown to 26 May 2020 date of application of MDR, creating challenges for devices that already have assigned UDIs due to obligations outside of the EU.
“We would like official confirmation that the ‘pseudo UDI’ allocation does not affect labelling or direct marking of devices,” COCIR states. Devices certified under the current Medical Device Directive (MDD) “can keep the current UDI (if existing) on the labels, direct marking and other technical files” and “UDI-DI identification should be accepted to identify MDD devices in Eudamed, under provision the same UDI-DI can be used for both versions (MDD and MDR) of the same device when those versions are identical.”
MDR’s framework “will have to be in place and functioning” in its entirety to realize the EU’s “ambition for medical devices” but it “appears that much effort is needed” to complete this work in time, COCIR says.
These issues, COCIR says, make the EU a “less attractive region” for manufacturers’ investment, but the group argues its recommendations “will help to address the most urgent concerns.”