Eurofins | Newsflash - March 2019 | Brexit: Medical Devices
Friday, March 8, 2019
BREXIT: the countdown
On 29th March 2017, the Government of the United Kingdom (UK) submitted the notification of its intention to withdraw from European Union (EU) according to Article 50 of the Treaty on European Union. The UK is due to leave the EU on 29th March 2019, at 12 pm UK time, and it will then become a third country not member of the EU. EU legislations will cease to apply in the UK. Currently, UK and EU are still negotiating a Withdrawal Agreement.
Both the European Commission and the United Kingdom make available on their websites the latest news about the on-going negotiations and information about the worst case scenario, ‘no deal’ Brexit scenario.
On 19th February 2019, the European Commission published: “Political declaration setting out the framework for the future relationship between the European Union and the United Kingdom (2019/C 66 I/02)”
If you are a manufacturer, importer, distributor, responsible person, retailer or consumer, it is important that you are aware of the possible ‘no deal’ Brexit scenario in which you may need to adopt different role and obligations from the current ones.
A brief summary has been included below for different sectors and how could the fact of not having an agreement between UK and EU affect them:
Due to the complexity of medical devices regulation, these products will not be subject to the new UK framework, and separate arrangements will apply.
Medical devices manufacturers having CE certifications obtained before the UK leaves the EU would continue to be accepted in the UK for a limited time.
The MHRA (The Medicines and Healthcare products Regulatory Agency), who is the UK national regulator for these products, has outlined a transition period for the registration of these products (from 4 to 12 months depending on the device).
The MHRA confirmed that medical devices that have obtained certification from UK-based notified bodies (NBs) will not be able to be placed on the EU market after Brexit in a “no deal” scenario as such certification will no longer be recognised by the EU.
On 4th January 2019, the UK government published guidance with information about the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal (see point 2. Medical devices). Click here to get this guidance.
On 2nd February 2019, the UK government published the guidance to replace the CE mark on products in the case of a no-deal Brexit scenario.
The UKCA (UK Conformity Assessed) would be the new UK mark to demonstrate compliance with the legal requirements to sell certain products in the UK.
Most products which are currently covered by CE marking would fall within the scope of the new UKCA marking. Products made in the UK which are exported to the European Union may have to be stamped with two marks - CE for EU market and UKCA for Great Britain and Northern Ireland.
In a “no deal” scenario, the results of conformity assessment carried out by UK conformity assessment bodies will no longer be recognised in the EU. Hence, UK manufacturers wanting to sell products that require conformity assessment and are not self-certifying (within the scope of CE marking legislations) in the EU will have to go through an EU recognised conformity assessment body (or arrange for assessments to be transferred to an EU-recognised body before the UK leaves the EU).
For EU manufacturers that wish to place products on the UK market that require conformity assessment, the UK will continue to recognise EU based Notified Body reports although an, as yet, undefined period of acceptance has been given.
Use Rules for UKCA would vary depending on the specific legislation that applies to the product. But the idea is very similar to CE mark with similar legal requirements (Technical documentation, Declaration of Conformity, marking, labelling, etc...) and responsibilities for manufacturer or responsible person placing the product on the market.
The European Commission and the UK Department for Business, Energy & Industrial Strategy have published the following information about the no deal scenario for Notified Bodies:
- Brexit – Guidance to stakeholders on impact in the field of industrial products.
- Guidance: Trading goods regulated under the ‘New Approach’ if there’s no Brexit deal
Key points are highlighted below:
Notified Body in EU
Notified Body in UK
Notified Bodies to be established in a Member State and be designated by a Member State notifying authority for performing the conformity assessment tasks set out in the relevant act of Union product legislation.
After Brexit, UK Notified Bodies will lose their status as EU Notified Bodies and will be removed from the Commission's information system on notified organisations (NANDO database).
They will automatically become UK approved bodies and listed on a UK version of the NANDO database and given a 4-digit approved body number.
Note: the current intention is that this will be the same number as the existing notified body number, to allow for identification of the relevant approved bodies responsible for CE marked products already in use or circulation on the market.
Where economic operators hold certificates issued by a UK Notified Body prior to the withdrawal date and plan to continue placing the concerned product on the EU-27 market as from the withdrawal date, they have several options:
Where UK notified bodies indicate that they do not intend to operate under the UK framework, their status will be withdrawn on exit day and they will not be listed in the new UK database of Approved Bodies. As part of this, bodies not intending to operate will need to either transfer relevant documentation to another approved body or the relevant government department or to retain relevant documentation for a specified period.
UKAS will continue as the UK’s appointed national accreditation body. Its role in accrediting UK Approved Bodies will be the same as its current role for UK-based Notified Bodies.
The UK Government and European Commission have made available a series of guidance documents with information on how to prepare if the UK leaves the EU with no deal. Below the list of the most recent documents:
- Trading with the EU if there is no Brexit deal: the implications for the trade of goods between the UK and EU countries
- Classifying your goods in the UK Trade Tariff if there is no Brexit deal
- Appointing nominated persons to your business if there’s no Brexit deal
- Trading under the mutual recognition principle if there’s no Brexit deal
- Brexit – guidance to stakeholders on impact in the field of industrial products