In the spirit of MedTech Europe's repeated and vocal calls to delay the implementation of the IVDR (see previous article here), Team-NB, the trade association representing 26 leading Notified Bodies, has issued a direct message to the medical device industry.
The message is clear - as things currently stand, Notified Bodies will not be able to cope with the titanic workload as a series of waves hit:
- the MDR comes into force in May 2021;
- the IVDR comes into force in May 2022; and
- the transition period expires in May 2024.
Team-NB has published a ruthlessly concise two-page position paper which calls for solutions to be discussed between regulators, the EU Commission and trade associations to avoid the impending crisis and beaching of medical device products in the EU. The position paper charts the results of a survey of all 54 medical device Notified Bodies (disappointingly only two thirds of whom responded) which reveals that over 13,000 certificates are due to expire before the end of the transition period in May 2024. Over half of these will expire in 2024 itself.
These statistics paint a bleak picture for the already-stretched Notified Bodies who are not only tasked with assessing the conformity and issuing certificates for devices entering the market, but who must also consider the increased requirements brought in by the EU MDR. This is exacerbated by the myriad of logistical problems the pandemic has introduced.
Team-NB proposes two changes that could bring some much-needed relief to the Notified Bodies.
The first of these is to allow Notified Bodies to conduct audits remotely. Pleasingly, on 11 January 2021, the Commission published a Notice permitting remote audits in certain circumstances. To date, the European Commission has been reticent to allow remote initial and surveillance MDR audits despite the COVID-19 pandemic's obvious impact, although it has allowed remote MDD audits.
The second suggestion is distinctly less specific and is to encourage manufacturers to spread MDR submissions over the next four years and not to leave them all to the end of the transition period. This suggestion in itself raises several questions about how this would be achieved and what incentives manufacturers would have for doing so, especially as they themselves are struggling to cope with the transition.
While it is pleasing to see all parts of the medical device industry voicing their concerns about challenges, it is also clear that the industry faces multiple waves of significant regulatory pressure in the near future and that strategic planning will be needed.
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