The Council of the European Union has issued a corrigendum amending the incoming Medical Device Regulation (MDR), which will give manufacturers of certain Class 1 devices more time to comply with the regulations.
The corrigendum clarifies that Class 1 devices that are in full compliance with the current Medical Device Directive (MDD) and are either: 1) reusable surgical instruments; 2) in sterile conditions; 3) have a measuring function, can remain on the market and in operation until May 26 2024.
While the amendment to the MDR still needs to be formally adopted by the European Parliament, it will likely come as a significant relief to some device manufacturers, many of whom have been scrambling to keep to the original deadline of 26 May 2020.
The delay is said to be to address the huge amount of “low-risk” items, such as forceps and scalpels, that would otherwise have been forced to undergo review.
An EC spokesperson said: "The Commission acknowledges that this inconsistency could affect a large volume of products and manufacturers and create significant pressure on the capacity of the Notified Bodies and the system as a whole. To grant this category of devices the same grace period as the other, higher risk ones, the Commission will support the co-legislators in case they intend to issue a possible corrigendum to the legislation."
However, along with full MDD compliance, the exempted devices must not change their design or purpose in the interim period and must still meet MDR requirements in relation to market surveillance and vigilance.