On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect. By that date, all current Class I devices according to the previous Medical Device Directive (MDD) wishing to continue in the EU should have effectively completed the transition and be fully compliant under the new MDR.
As already explained in a previous post, new classification rules have been in place with the new MDR and manufacturers may find that additional classification rules are applicable to their devices, with some products up-classified from Class I to Class IIa, IIb or even III.
This is the situation of many substance-based medical devices, which according to the new rule 21, from next May 26th, 2020, can no longer be classified as Class I if they are absorbed by the body. Wetting agents, nasal and throat sprays, ear drops, etc., currently on the market as Class I will now fall under a new category, which contrary to its previous classification, requires input from a notified body.
While non-Class I manufacturers that have been recertified under the medical device directive before the 2020 deadline may benefit from an extended deadline up to 2024 (the famous Grace Period), Class I manufacturers have not been accorded such a margin for maneuver and consequently will need a notified body for the first time under the MDR, which would significant increase pressure on the capacity of the notified bodies, unable to attend such a large volume of products and manufacturers.
Threatened for the potential supply bottlenecks for this low risk medical devices, some authorities such as the German and Irish laid out their concerns about this problem and called for solutions to the European Commission.
While there has still been nothing official from the European Commission, several sources (Medtech Inshigh, MEP Peter LieseandPolitico) has published articles about the possibility of a corrigendum of the Commission extending the deadline for low risk medical devices, expanding the range of products (class I) that could benefit for the four year grace period.
This hypothetical scenario would release the pressure sufficiently on the sector to allow Notified Bodies focus on higher-risk products, would prevent a shortage of the sanitary market for basic devices and would facilitate the transition for class I manufactures.
However, it is not yet clear that this announcement of the Commission is going to take place and, more important, if all class I medical devices categories could benefit from this possible Grace-Period, since most news suggest that only some categories such as class I reusable surgical instruments would be included in the corrigendum.
Therefore, while waiting for the next steps of the Commission and being benefited or not for a longer transition period, Class I medical devices manufacturers must start the process for MDR compliance now to avoid trade repercussion, being recommended reach out to regulatory expertise, particularly for Class I manufacturers that are affected by medical device regulations for the first time.