The European Commission has posted on their website a Questions and Answers related to the UK’s withdrawal from the EU, in case of a no-deal scenario. This document is a must read for all companies placing products on the UK market and/or having conformity certificates issued by a UK Notified Body.
Key elements contained in this document:
- Products, manufactured in the UK or imported from a third country by UK importer or products with EC certificates issued by a UK notified body (NB) which are placed on the EU market prior to the UK withdrawal date (March 30th 2019 at 00:00h) can continue to be made available in the EU market, or remain in use, with no need for re-certification, re-labelling or product modifications.
Placing on the market is defined as the first supply of a good for distribution, consumption or use after the manufacturing stage.
- UK-based EU Authorised Representatives will lose their status as of the withdrawal date, regardless whether the product has been placed on the market. Manufacturers are obliged to appoint a new Authorised Representative established in the EU. For goods placed on the EU market prior to the withdrawal date no relabelling required. For goods placed on the market as of the withdrawal date they must be fully compliant with EU law and thus have the correct labelling.
- UK-based importers and manufacturers will lose their status as an EU Economic operator, as of the withdrawal date. The EU based economic operators receiving goods from a UK manufacturer or UK based importer, which were previously mere distributors of those products will become importers for the purposes of Union law when making those products available in the EU market for the first time.
- EC certificates issued by a UK NB will no longer be valid and an EC certificate issued by an EU-27 NB will be required. Economic operators must either apply for a new certificate with an EU-27 NB or arrange for a transfer of the file and the corresponding certificate to an EU-27 NB. The transfer of certificates from a UK NB to an EU-27 NB needs to take place before the withdrawal date, on the basis of a contractual arrangement between the manufacturer, the UK NB and the EU-27 NB.
For products placed on the EU market after the withdrawal date both the EU Declaration of Conformity (drawn up by the manufacturer) and the NB Certificate must be updated accordingly.
Products manufactured after the transfer of the certificate has taken place should be marked with the new EU NB number. The products placed on the market and/or manufactured prior to the certificate transfer do not require re-labelling.
At the end of January, new regulations that amend the UK’s 2002 Medical Device Regulations were laid down by the UK parliament. The objective of the amendment is to enable UK device rules to fully function in a no-deal Brexit scenario. The proposal mirrors key elements of the EU Medical Device Regulation (MDR) and IVD Regulation (IVDR) in UK law and will be brought into force in line with the transitional timetable being followed by the EU for the full application of those two Regulations. Manufacturers wishing to place a device on the UK market will need to comply with the amended 2002 Regulations.
The main points device industry should be looking out for in the new regulations are set out in MHRA’s further guidance note, which was published on January 3rd, 2019.
- CE marking: In a no-deal scenario, UK will continue to allow devices to be placed on the UK market that are in conformity with the applicable EU Directive for a, yet unknown, limited period of time.
- Notified bodies: As mentioned above, in a no-deal scenario, UK-based notified bodies (NB) will no longer be recognized by the EU after the withdrawal date. This implies that the devices with a EC certificate issued by a UK NB will no longer be in conformity with the applicable EU Directive. However, in the UK, to ensure continuity in supply, UK NBs will be given an ongoing legal status and certificates they issued prior to the withdrawal date will continue to be recognised in the UK after the withdrawal date, thus allowing these products to be placed on the UK market.
- New registration requirements: all medical devices, active implantable medical devices, in vitro diagnostic medical devices (IVDs) and custom-made devices, placed on the UK market after the withdrawal date will first need to be registered with the MHRA. This registration requirement will be subject to a grace period as it is an extension of the current regulations. If the device manufacturer is not established in the UK, the registration with MHRA will have to be done by a “UK Responsible Person” established in the UK, with a UK registered address and who will take full responsibility of the product in the UK.
What does this mean to you?
If you are a UK manufacturer or if you are currently working with a UK-based Authorised Representative, ensure that you have an EU mainland based Authorised Representative and have handled all administrative tasks related thereto to ensure you can access the EU market after the UK withdrawal date.
If you have EC Certificates issued by a UK NB, take immediate action and ensure you have the necessary contracts in place to transfer your existing certificates to a new EU based NB, unless you have already started a new certification process with an EU NB. Carefully review production planning and manage your inventory as no transition periods have been proposed, and all products placed on the EU market after the withdrawal date must be fully compliant to EU law and thus labelled accordingly.
If you wish to market your product in the UK, select your UK Responsible Person and establish who will be your UK importer.
Contact us if you require in-depth information, training or support.
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