From a technical standpoint, the MHRA’s requirements will still be in line with the EU’s MDD. The plan is to amend these regulations in 2023 and the MHRA is already in the process of drafting these changes. The MHRA is using this period as an opportunity to avoid any pitfalls that present themselves in the EU with the MDR. This plan, in theory, should lead to a more efficient implementation process come 2023. However, it is still crucial that manufacturers stay up to date with any announcements from the MHRA leading up to their 2023 amendments.
Regulatory Labelling Changes
While the UK regulation accepts CE marked products with the EEA Notified Body number until July 1st 2023, you must be prepared to re-label after that date. The device industry is still waiting on the guidance from the EU as to when the cut-off date will be for accepting CE marked products from the UK and any necessary requirements for re-labelling. This is certainly an aspect manufacturers will want to keep an eye on moving forward.
Device manufacturers based outside of the EU can no longer rely on a Great Britain based Authorized Representatives (AR) for their devices to be placed on the EU market. They must now appoint an Authorized Representative in the EEA. The Great Britain AR will no longer be recognized in the EU, which officially went into effect on January 1st 2021 regardless of when the products were originally placed on the market.