Key Points:
  • All CE rules will continue to apply until we have actually left the Single Market
  • UK influence on the rules is already greatly diminished
  • CE marking is integral to the Single Market so we will need to apply the rules if we want to continue to trade with the EU, even if UK decides to repeal some of them for internal trade
  • Essential requirements are heavily integrated into our occupational health and safety regime
  • Environmental requirements are the ones most likely to be axed

It's now nearly nine months since the UK Government invoked Article 50 and it's still anybody's guess what the UK's relationship with the single market will look like after Brexit. 

It's going to be several years before we see any significant changes to the UK legislation implementing the CE Mark directives. Even then, the directives 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. 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 The current presumption whereby British Standards are withdrawn in favour of Harmonised European standards has never been mentioned in the debate about Brexit and it seems likely that it will remain for the foreseeable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.

 
Brexit FAQ:
After Brexit, will I be able to import products that are not CE marked and use them in my premises or resell them in the UK?

As things stand at present, the Great Repeal Bill won't actually repeal anything. Instead, what it will do is incorporate all current EU legislation into UK law on 29 March 2019. Only after that date will the UK parliament be able to modify the laws which require CE marking for products sold within the UK. It seems likely that this won't be a priority for some time so the answer to the question is 'no'. 

I'm a UK based manufacturer of CE Marked products/equipment. I only sell my products/equipment within the UK. Do I still need to CE Mark it or is there an alternative route I can follow?

CE Marking is currently the law in the UK and for the next 3-5 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.

I'm a UK based manufacturer of CE Marked products/equipment. I sell my products/equipment within the EU. Do I have to submit my techncial file to a European Authority?

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-EU-Point' offers.

I'm a UK based manufacturer of Medical Devices. I sell my products/equipment within the EU. Do I have to submit my techncial file to a European Authority?

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.

Will EN standards still be applicable or will we revert to BS standards only?

The normal approach to demonstrating compliance with the various directives is to assess the product with respect to Harmonised standards that are cited in 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 Harmonised standards as National standards (EN become BS EN) and leaving the EU won’t affect that process.

I've heard that some people want to align us more closely with the US. What is the impact of this likely to be on product safety requirements?

The UK and the US have fundamentally different approaches to product safety in a significant number of areas. For example, US electrical safety standards are based more around preventing fire whereas UK/EU standards tend to treat protection against electric shock as the priority. By far the majority of global standardisation effort takes place in Europe and recent experience indicates that the US is aligning its standards more closely with those of the EU rather than the other way around. Products made to US standards will be acceptable in the UK, but only where those standards are aligned to those of CEN and CENELEC.

I want to purchase a Doc-Eupoint license, how will Brexit affect this service?

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.

Further advice

For further information and advise please contact us at Conformance and we will be pleased to help.

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