The never-ending story. Does it end now? 

According to the recent news, we have a high probability of a very hard Brexit.  

Here you can find the NEW MHRA guidance in regards to the new proposed exit strategy for the medical devices industry. 

A new law is planned and should come out toward the end of the year. Therefore, whatever is being stated should be taken with a grain of salt. Changes are still possible. The MHRA certainly can be viewed as a trusted source, but certainly, the actual law will always prevail. 

The first and most important questions by our clients up to now are the following: 

 1. Can MDSS provide the new UK responsible person (UK RP)? 

MDSS is committed to provide the UK RP service and has opened up a legal entity in the UK specifically for that purpose. However, providing an independent UK RP service may not be possible, or there simply may be no value to you. Currently it seems the UK RP has been given its own name but may by default be the IMPORTER. An independent UK RP may not be desired by the UK. We work diligently to get confirmation on UK RP status. As soon as we receive feedback, we will inform you accordingly and we will offer our UK RP service. 

Here are our views: 

Certainly, a UK RP being the importer does not make any sense at all. Just furnish the importer with the requirements and delete the term “UK RP" to avoid confusion altogether. In any case, the UK RP requirements are similar to the new EC REP requirements under the MDR/IVDR. Here is the danger for a manufacturer exporting to Europe: Providing the importer, and sometimes several importers, with the details of your products via the technical file can be dangerous to your intellectual property. The risk is eminent since every customer of yours in the UK is actually the importer of your product – if the international rules of importation still apply in the UK. 

Should indeed the importer be the UK RP, then the manufacturer must act upon streamlining the export to the UK.    

2. Do we have enough time to adjust to the new requirements? A transitional period is provided by the guidance, which should be sufficient for the Economic Operators to adjust. Actually, there will be three transition periods: 

      a.    For the application of a new UK CA mark with the requirement to entirely comply with the new UK law - until June 30, 2023. Therefore, CE mark products may be placed on the market until that date. 

      b.    However, new registration requirements apply from January 1 with the transition of 4, 8 and 12 months based on the risk class of products. 

      c.    The UK RP will have to be implemented by the time you register the product.  It is actually the UK RP who would perform the registration, contrary to the MDR where the manufacturer must perform the registration of products. 

The MHRA guidance provides a bird’s - eye view on the upcoming new UK regulations, and many details will only be available with the publication of this new law. This guidance is short but quite meaningful. Please take this guidance into consideration, in particular the timeline given. We are ready to provide the service.