On 8 October the UK Government issued its “No Deal Readiness Report”. Whilst it is not yet known whether the UK will leave with or without a Withdrawal Agreement at the end of October, the report sets out guidance for industry across a range of sectors – including providers of medicines and medical devices.
Guidance can be found via the link here. Please see page 78 and further for the guidance on the various legislation per industry sector.
In summary, if there is no deal:
The UK would manage its own set of regulations on manufactured goods separate from the EU if we leave without a deal, and UK businesses exporting to the EU would need to meet EU rules.
Many manufactured goods sectors, such as chemicals, aerospace goods, human and veterinary medicines, medical devices and automotive vehicles, are subject to common rules across the EU. These rules establish common requirements for manufacturing, testing and marketing products from these sectors. Currently, it is a legal requirement to follow these rules before selling regulated products in the EU.
Having separate regulatory regimes for manufactured goods will mean that:
- The UK will be able to set its own regulations that the businesses in the EU and other countries will have to follow before selling products on the UK market. This means that the UK could set regulations for imports into the UK rather than having to follow EU regulations.
- UK businesses exporting to the EU will need to make sure they meet EU rules. This includes, where relevant, having goods approved by EU-based bodies or having legal representatives in the EU.
- Approvals and authorisations on goods issued by UK bodies will not be accepted in the EU, even where these meet EU regulations or were issued by a UK body while the UK was still an EU member state. However, there are some exceptions to this if the EU has made a short-term commitment to accept goods.
- The UK will no longer be part of any ongoing EU agency or regulator activities. For human and veterinary medicines, chemicals and aerospace products, the relevant EU agencies which play a role in regulating goods are the European Medicines Agency (EMA), the European Chemicals Agency (ECHA) and the European Aviation Safety Agency (EASA) respectively. UK regulatory bodies will no longer be able to license products for the EU market and the UK will no longer participate in relevant committees.
- UK regulators will take on regulatory functions currently carried out by EU regulatory bodies.
The UK Government’s preparations for leaving without a deal:
- The Government has introduced new regulations to accept goods made against EU rules (including goods subject to assessments made by EU conformity assessment bodies) in the UK. This will mean that goods with the CE mark (which also include toys, electronics and machinery) can still be sold in the UK.
- The Government will provide continuity in goods regulation for a temporary period after exit day in order to provide as much stability as possible for businesses immediately following the UK leaving without a deal.
- For the automotive, chemicals and medicines sectors the UK is putting in place light-touch processes to allow businesses to convert existing EU approvals into UK approvals.
- The UK Government will introduce a new UK regulatory framework for CE-marked goods that will allow manufacturers to show that products meet UK rules and can be sold in the UK. This will include introducing a UK-only mark -called the UKCA mark -and a system of UK Approved Bodies. The UK Government published advice on using the UKCAmark.
- The CE mark will be retained for medical devices to ensure continued access for UK patients. Section B sets out the UK Government’s preparation for the regulation of medical devices.
- The UK Government has published technical notices on placing manufactured goods on the UK and EU markets after Brexit, as well as on what has changed across the product safety and legal metrology regimes, and consumer rights. There is dedicated, tailored advice available for the chemicals, medicines, veterinary medicines, construction, aerospace, rail and automotive sectors.
The UK Government has intensified preparations since 24 July 2019 on the following topic:
- The UK Government is preparing a new public database of conformity assessment bodies who will be able to assess products against UK rules before they are UKCA-marked.
- The UK Government will engage with industry before making any changes to regulatory arrangements, and, in the event of any changes, the UK Government is committed to giving sufficient notice of any change. The UK Government will give two years’ notice of any changes to regulations for medical devices.
- The UK Government has refreshed the information in all of the aforementioned technical notices with up-to-date advice for businesses.
What Brexit Means For Businesses:
All businesses who manufacture, trade or distribute manufactured goods should take action.
All businesses who manufacture, trade or distribute manufactured goods should take the following actions:
- Check all relevant guidance available on GOV.UK and pay close attention to the UK Government’s Brexit communications campaign for more details on the actions required to prepare if we leave without a deal.
- Check whether they need new product approvals, whether they need to appoint new representatives in the EU, make changes to the labels and markings on their goods, or submit information to new UK systems.
- Check what actions they or their suppliers need to take in relation to the manufacture and import of chemicals so that they continue to receive necessary ‘input’ goods. These actions are listed below.
Manufacturers of goods currently regulated under the EU’s ‘new approach’ (i.e. mostly CE-marked goods) should take the following specific actions:
- Businesses exporting CE-marked goods should check whether their goods are supplied in the EU via an EU-based distributor. If so, that distributor will become an importer. UK distributors of CE-marked goods from the EU will also become importers. Importers have certain legal responsibilities, including making sure products are accompanied by their address.
- Where businesses are required under EU law to get third party approval of their goods, they should confirm whether current approvals are issued by a UK or EU-based notified body. If unsure, the business will need to check with its notified body as in some cases, they may be making arrangements on businesses’ behalf. If the business uses a UK notified body but plans to continue to export CE-marked goods to the EU, further arrangements should be made to have the products approved by an EU recognised notified body. To do this, the business can either get the products reassessed by an EU recognised notified body or arrange for the files to be transferred to an EU notified body before the UK leaves the EU.
- If the business only sells to the UK market and uses a UK-based notified body, action should now be taken to be ready to use the UKCA mark.
- For medical devices, there will be no UKCA marking so all devices sold in the UK will continue to require the CE marking (see below for details).
- Businesses who currently use an Authorised Representative to act on their behalf should confirm where their Authorised Representative is located. EU-based Authorised Representatives who received their mandate before 31 October 2019 will still be recognised in the UK after 31 October 2019. However, a UK-based Authorised Representative will not be recognised in the EU as able to fulfil this role after 31 October 2019.
- UK businesses who export machinery to the EU will need to make sure they have nominated a person authorised to compile technical files who is based in theEU. This person could also be an importer or Authorised Representative.
- Where businesses have made any changes to how their product is approved or marked, or if there is a new importer or Authorised Representative, they should draw up a revised declaration of conformity with the correct details. Where the CE marking is used, this should still be an EU declaration of conformity. If the UKCA marking is used, then it will need to be a UK declaration of conformity.
- Businesses that self-certify compliance withEU law and place the CE marking on the product can continue to do so.