Dive Brief:
- The European Commission in an update this week said three more notified bodies have made it to the final stage of certification under incoming medtech rules in the EU and are awaiting official publication in the NANDO database.
- The relatively few certification firms designated under the Medical Device Regulation — so far there are nine, compared to the 49 designated under the longstanding Medical Device Directive — has been an increasing concern for industry, as the May implementation date for MDR stands four months away. The In Vitro Diagnostic Regulation, which takes effect in 2022, currently has three working notified bodies, in contrast to 20 designated under MDD.
- The new designations would move the Commission a step closer to its goal of having 20 notified bodies in place by the end of the first quarter of 2020.
Dive Insight:
The lack of notified bodies capable of assessing medical devices under forthcoming regs is one of the most pressing concerns related to their implementation. At one point last year, the EC aimed to have 20 notified bodies in place by the end of 2019. In the end, the Commission closed out the year with nine MDR-designated notified bodies, plus three covering the diagnostics regulations.
The EC indicated it has received applications for MDR designations from 44 notified bodies, meaning it is on track to ultimately certify most of the currently authorized groups to assess devices under the new rules. Half of the current in vitro diagnostic notified bodies have submitted applications, in addition to one application from a newcomer.
However, many of the notified bodies still need to go through multiple steps before receiving their designations. Having received a combined 55 applications across MDR and IVDR, the EC has completed 45 on-site assessments. That has led to the submission of 25 corrective and preventive action (CAPA) plans. A further 20 such plans are pending. The EC listed four pending on-site assessments in 2020 (two for MDR, two for IVDR).
Twenty-one notified bodies have reached the joint assessment team CAPA review stage. Of those, 13 have received a final opinion from JAT, putting them on the cusp of a designation. As 12 notified bodies have already been designated, that suggests only one more authorization to assess devices under MDR or IVDR is imminent. All other applicants need to complete at least the JAT CAPA review and receive final reports and opinions from JAT and the designating authority.
Industry group MedTech Europe doubts whether the designations will happen quickly enough to ensure sufficient notified body capacity is in place, leading it to push for contingency measures.
“Even when designated, a Notified Body needs at least 6 months for each single certification, yet fewer than 6 months remain until 26 May 2020,” MedTech Europe wrote in a December call to action. The group also noted that MDR-designated NBs still have responsibilities outside of the new rules, such as renewing certificates under existing regulations and conducting surveillance of products already on the market.
Notified bodies currently authorized for MDR work are BSI (U.K. and Netherlands), Dekra (Netherlands and Germany), TÜV Rheinland (Germany), TÜV SÜD (Germany), Medcert (Germany), IMQ (Italy), and Dare!! Services (Netherlands). IVDR notified bodies are BSI (U.K. and Netherlands) and Dekra (Germany).
