On May 26, 2021, the European Union (EU) implemented REGULATION (EU) 2017/745, the “Medical Device Regulation,” or MDR. Ever since, the medtech community in Europe has been struggling with its implementation. This struggle largely relates to the capacity shortage at the Notified Bodies (NBs), the auditing companies that handle regulatory approvals. This and other issues have been voiced by multiple national and European industry organizations, and I discussed the effects on the focused ultrasound medical device industry in a June 2022 blog.
MDR’s Disruption and Impact
More recently, the consequences of this capacity shortage have also gained mainstream media attention. The problem is a very fundamental one, affecting all aspects of healthcare that need medical devices. All such devices on the market and in use today in Europe need re-certification under the new MDR. Yet, the responsible authorities cannot keep up with the assessments; of the approximately 23,000 required certificates, just 1,990 had been issued by October 2022, according to a report by the European Commission to the EU Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) in December 2022.
The certification procedures drag on: they take 18 months on average to complete. If this continues, the EU Commission expects the number of MDR certificates issued by the May 2024 deadline may reach just around 7,000, and the remaining 70 percent of certificates will expire. Corresponding instruments or devices should then no longer be used, and this includes pacemakers, angioplasty catheters, hip implants, and many more. MedTech Europe shares on this topic.
Suggested Amendments May Extend the Deadline
Fortunately, the EU Commission has been listening. At the meeting of the European Health Minsters, the Commission proposed to extend the recertification deadline. This extension would be based on the risk classification of devices and would mean that devices certified in accordance with the Medical Device Directive (MDD) will remain on the market in the European Economic Area (EEA) after the end of the currently applicable transition period. Specifically, the European Commission proposes the following targeted legislative amendments:
- An extension of the transitional period in Article 120(3) MDR with staggered deadlines would be granted based on the risk class of the device. Those deadlines would be 2027 for class III and class IIb devices (i.e., devices with a higher risk) and 2028 for class IIa and class I devices (i.e., lower risk devices) that need the involvement of a notified body in the conformity assessment.
- The extension of the transitional period could be combined with an extension of the validity of certificates issued under the obsolete MDD by amending Article 120(2) MDR.
- The extension should apply only to devices that do not present any unacceptable risk to health and safety and have not undergone significant changes in design or intended purpose.
- The removal of the ‘sell off’ provision for medical devices that are already available on the EEA market to prevent safe medical devices from being removed from the market.
To ensure a uniform approach in bridging the gap between the expiration of certificates and the issuance of new certificates, the European Commission recently published a position paper prepared by the Medical Device Coordination Group. This paper provides guidance on how competent authorities should apply Article 97 MDR to devices that do not comply with the MDR due to expiration of their CE certificates of conformity issued in accordance with the MDD before being certified under the MDR.
The suggested amendments would help address the most immediate issues of re-certification of existing devices, but they are not likely to solve all. Small- and medium-sized enterprises may continue to struggle regarding certification of new devices (as discussed in the June 2022 blog).
Forthcoming Review Is Promising
There is some criticism that the new regulations introduced by the MDR are simply over-regulation. In that context, one of the final paragraphs in the Commission’s report to the Health Ministers discusses a comprehensive evaluation of the MDR by May 2027. The purpose of the evaluation is to identify structural problems with the MDR, as well as potential medium- and long-term solutions to these concerns.