The European Commission’s Medical Device Coordination Group (MDCG), has undertaken a survey to collect data on notified body certification and application activities under the Medical Devices Regulation (EU 2017/745) (MDR) and In Vitro Medical Devices Regulation (EU 2017/746) (IVDR). The MDCG is composed of representatives of Member States and chaired by the EU Commission. Previous MDCG recommendations in a position paper (MDCG 2022-11) indicated that medical device manufacturers should step up their efforts to obtain MDR compliance in order to avoid a potential device supply shortage in the EU.
The MDCG survey includes responses from 47 European notified bodies. The data indicate a total of 22,793 valid certificates are in place for the Directives for medical devices and active implantable medical devices. Of these valid certificates, 6% (1,387) expire in 2022 and 19% (4,311) expire in 2023. This leaves 75% (17,095) expiring in 2024, suggesting that medical device manufacturers’ strategies for MDR compliance have aimed at maximising the period of validity of certificates to the Directives. It is interesting to note that 487 of the certificates expiring in 2024 are for devices with an ancillary medicinal product that requires consultation with a Competent Authority for medicinal products as part of its conformity assessment.
As of October 2022, the survey indicates that there have been 8,120 applications for MDR certificates and 1,990 certificates have been issued. The survey also indicates the timelines for the issue of MDR certificates. For Quality Management System (QMS) certification, the data show that time for certification has been less than six months in 27% of the applications and six to 12 months for another 27%, whereas 40% of applications took 13 – 18 months, and 7% took 19-24 months. However, for both QMS and product certification, 82% of applications took 13-18 months and the remaining 18% took 19-24 months.
The survey also provided data for certificates to the IVDR. In terms of valid certificates, the data indicate a total of 1,551 valid certificates have been issued, with 56% (866) of these expiring in 2025. However, it should be borne in mind that with the change in the classification system for in vitro diagnostic devices (IVDs) in the IVDR, many more certificates will be required than was the case under the Directive for IVDs. In October 2022, there had been 822 applications for certificates for IVDs and 268 certificates had been issued. Concerning the timelines for issue of IVD certificates, no QMS certificates were issued in less than six months and 14% of product and QMS certification took six to 12 months, but otherwise the timelines were of a similar order to certification to the MDR.
These data show the problem that is emerging in the transition to the MDR and IVDR, with a significant number of certificates for legacy devices expiring in 2024 for medical devices. At the current rate of certification, all existing products cannot be transitioned by the current deadline. On 6 December 2022, the European Commission indicated that it was prepared to present a proposal to amend the MDR to provide more time for transition. This could include:
- an extension of the transitional period with staggered deadlines depending on the risk class of the device; and,
- an extension of the validity of certificates issued under the Directives;
with conditions to ensure that the extension applies only to devices that do not present any unacceptable risk to health and safety, have not undergone significant changes in design or intended purpose and for which the manufacturers have already started the certification process under the MDR. In addition, the MDCG issued a position paper (MDCG 2022-18) on applying Article 97 of the MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate. Article 97 relates to situations in which a Competent Authority finds that a device does not comply with certain MDR requirements but does not present an unacceptable risk to health and safety of patients, users or other persons, or to other aspects of the protection of public health.
The precise actions and conditions have not yet been finalized. Manufacturers should watch for more information, review their strategies for transition and engage with their notified bodies to examine the feasibility of those strategies. It would be beneficial for manufacturers to also review their processes for managing regulatory information and see if Compliance Navigator can assist in improving their efficiency and effectiveness.
This content originally appeared on BSI’s Compliance Navigator blog.
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