It’s likely that it will be at least six months before any clear view of how Brexit will be achieved emerges, and two years before we see any significant changes in UK legislation. Even then, all of the Directives on which CE marking is based are single market measures which are exactly those that the exit campaigners wish to preserve. By voting for exit, the UK has now forfeited a substantial proportion of its influence over how those measures will be developed in the future, but the legislation will remain in place in Europe and UK companies will have to abide by it if they wish to continue to sell into the single market.
As things stand at present, the exit will have no effect on the UK’s participation in the European standards bodies, CEN and CENELEC. The current presumption whereby British Standards are withdrawn in favour of Harmonised European standards has never been mentioned in the debate about Brexit and it seems likely that it will remain for the foreseeable future. Since the majority of the detailed design measures for CE marked products come from standards, there will be little practical change so far as equipment designers are concerned.
In the long term, clearly there will be some divergence between UK and EU requirements for product safety. Conformance Ltd will continue to work hard to identify what’s actually required in the EU market and inform all our customers, both in the UK and elsewhere, what they need to do to legally sell their products. We are confident that our pragmatic approach based on a sound technical understanding of the requirements and a unique strategic understanding of the CE marking process will continue to ensure that our customers' needs are met.
This is a subject that the National Authorities still have to clarify: will the pre-existing laws, based on European CE marking, be replaced or will they be endorsed and maintained in the national legislation?
CE Marking is currently the Law in the UK and for the next 1-2 years we expect no change. There will always be a need for UK legislation to control the safety of equipment and we expect that as the CE Marking system has been accepted for 20+ years throughout Europe, the UK will continue to adopt this sytem for the future to ensure we maintain product safety and free trade.
Once the Brexit will take effect, you will have to make the technical file available on the EU territory; it is not required that the TF is stored at a European Authority: a business partner, a lawyer, etc. are sufficient only if they are available and capable to submit the TF on request of a Competent Authority. This is what our service 'Doc-U-Point' offers.
It is required that non-EU manufacturers of Medical Devices appoint an Authorised Representative (AR) within Europe. This legal person will need to co-operate with you in implementing the Post Market Surveillance procedures. According to the agreement that you set in place, the AR can also perform other activities.
The normal approach to demonstrating compliance with the various directives is to assess the product with respect to Euro-Normalized standards that are cited within the Official Journal and provide a “presumption of conformity”. The United Kingdom is a full member of the European Committee for Standardization (CEN) and adopts Euro-normalized standards as National standards (EN become BS EN), leaving the EU won’t affect that process since its completely independent, directives and standards are related but not the same.
Current estimates indicate that it will be at least two years before the withdrawal process is completed. It is too early to say yet exactly how the relationship between the UK and the EU will work once the process is completed but it is likely that the Machinery Directive will remain in force within the UK so that UK companies can continue to take advantage of the single market. This would enable us to continue to offer Doceupoint services as we do at present.
If the UK does not remain part of the single market, Conformance Ltd will re-locate its Doceupoint service to a country within the Union to ensure we can continue to provide the service to our clients. In this event, we will supply all clients with updated contracts and Declarations of Conformity.
We will continue to keep you updated as the UK exit plans progess, but you can be assured that the Doceupoint service will continue irrespective of the UK’s status as an EU Member State and you need have no concerns that your Doceupoint service has become, or is about to become, invalid.
For further information and advise please contact us at Conformance and we will be pleased to help.