Wellkang is a registered EU Authorised Representative (EC Rep) in the European Commission's EU medical device database EUDAMED under a unique Single Registration Number (SRN): XI-AR-000001836 for the markets of EEA/EU27 & Northern Ireland.
Wellkang is also a registered UK Responsible Person (UKRP) in the UK MHRA medical device database for the market of Great Britain: England, Wales & Scotland, after 1 Jan 2021, which is no longer part of the EU single market after Brexit.
Are you ready for Brexit impacts? Do you have a Brexit contingency plan?
You may need either an EU/EC European authorized representative based in EU-27 countries or a UK authorised representative (so called "UK Responsible Person") based in UK, or may even need both EU & UK representatives, depending on different brexit scenarios.
Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical
Devices with MHRA in UK & other EEA (EU/EFTA) authorities by world-leading
consultancy- Wellkang team based in both UK (England) & EU-27 (Ireland).
Wellkang team can help you under all Brexit scenarios!
Click here to get FREE Guide Now!
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FAQ & Guide on Brexit:
Are you ready for Brexit impacts? Do you have a Brexit contingency plan?
Do you need an EU or UK authorized/authorised representative (UK Responsible Person), or both?
Wellkang can help under all Brexit scenarios! We are based in both UK (England) & EU-27 (Ireland).
Warning for Brexit impacts & Brexit contingency plans:
If there’s no Brexit deal between UK & EU, i.e. under a cliff-edge hard Brexit, you MUST have a Brexit contingency plan if you place products on either UK or EU27/EEA markets!
- Plan A (for non-UK manufacturers):
NEW UK authorised representative (so called: UK Responsible Person) needed.
The NEW UK authorised representatives (UK Responsible Person) (UKAR/UKRP), based in the UK, such as Wellkang UK offices, will be needed, under UK law, for ALL non-UK manufacturers including both non-EU manufacturers and EU27 manufacturers (or EU-27 distributors of non-EU manufacturers) who place certain products on the UK market: either directly or via EU-27 distributors, via traditional way or via online sale via Amazon. Ebay, etc.
- Plan B (for non-EU manufacturers using UK AR currently):
NEW EU authorised representative needed.
All non-EU manufacturers, who use currently UK-based authorised representatives and continue placing CE-marked products such as Medical Devices on the markets of EU27 and other EEA member states, will need to appoint a NEW EU authorised representatives (EAR), such as Wellkang's Ireland offices, based in the EU27 countries under EU laws.
- Plan C (for UK manufacturers):
NEW EU authorised representative needed.
All UK manufacturers who place certain CE-marked products such as Medical Devices on the markets of EU27 and other EEA member states will need to appoint a NEW EU authorised representatives (EAR), such as Wellkang's Ireland offices, based in the EU27 countries under EU laws.
Being based in both UK & EU27, Wellkang team can help you under all Brexit scenarios! Click here to contact Wellkang team now!
What are the impacts of Brexit on CE marking and medical devices (MD/IVD) placed on the markets of the EU27/EEA and/or of the UK?
Depending on different Brexit scenarios, Brexit may have the following imparts on CE marking and medical devices (MD/IVD) placed on the markets of the EU27/EEA and of the UK:
- 1. Brexit impacts on EU Authorised Represenatives based in EU27 countires for non-EU manufacturers who place CE-marked product on the market of the UK.
- 2. Brexit impacts on Manufacturers (or non-EU manufacturer's distributors) based in EU27 countires who place CE-marked product on the market of the UK.
- 3. Brexit impacts on Manufacturers (or non-EU manufacturer's distributors) based in the UK who place CE-marked product on the market of the EU-27/EEA.
- 4. Brexit impacts on EC certificates issued by UK-based Notified Bodies for products placed on the markets of the EU27/EEA and/or of the UK.
- 5. Brexit impacts on EEA/EC Authorised Represenatives based in the UK for non-EU manufacturers who place CE-marked product on the market of the EU27/EEA.
Being based in both UK & EU-27, Wellkang team can help you under all Brexit scenarios! Click here to contact Wellkang team now!
Current Brexit Status
Both the United Kingdom (UK) & European Union (EU) have now already agreed the terms of UK's exit from the EU, as set out in the Withdrawal Agreement. This was agreed by the EU Member States at the special European Council on Sunday 25 November. Both also agreed the terms of the future relationship, as outlined in the political declaration.
The deal agreed will allow the UK to leave the EU in a smooth and orderly way on 29 March 2019 and sets the framework for a future relationship. UK takes back control.
The deal (Withdrawal Agreement) must now be voted upon in UK Parliament in January 2019. In keeping with the clear intention of section 13 of the EU (Withdrawal) Act, the UK Government will ensure the matter is brought back to the UK Commons before 21 January. If Parliament approves the Withdrawal Agreement and framework for the UK’s future relationship with the EU, the UK Government will bring forward the EU (Withdrawal Agreement) Bill to give the Withdrawal Agreement domestic legal effect.
What are likely/possible brexit scenarios?
- 1. No Brexit (Brexit is cancelled or delayed)
It is still possible that Brexit is cancelled by means of the follows:
withdrawing of the Brexit Treaty (Withdrawal Agreement) by Prime Minister Theresa May;
"Second referendum (people’s vote)";
"meaningful vote" by the UK Parliament;
another general election, change of government;
- 2. Brexit is delayed (Extend article 50)
European council agrees to extend article 50. The UK will NOT exit the EU on 29 March 2019.
- 3. Softer Brexit than Theresa May's Brexit Treaty
EEA model (Norway model): remaining in single market & accepting 4 free movements;
EEA+ model (Norway plus model): EEA model plus Custom Union;
Theresa May's draft Brexit Treaty plus permanent Custom Union;
- 4. Theresa May's Brexit Treaty (Withdrawal Agreement)
After 29 March 2019, UK enters 2 to 4 years transition period until 31 Dec 2020, or even 31 Dec 2022. During the transition period, as a non-EU member, the UK will continue to participate in the Customs Union and the Single Market (with all four freedoms), like Norway does today, Business as usual!.
During the transition period, EU & UK will negotiate a bespoke future trade agreement: a so-called free trade area for goods, i.e. partial single market for goods only (similar to Swiss Model today), plus ambitious customs arrangements that build on the single customs territory.
The follows are stated in the Outline of the political declaration setting out the framework for the future relationship between the European Union and the United Kingdom of Great Britain and Northern Ireland, as agreed at on 14 November 2018.:
Comprehensive arrangements creating a free trade area combining deep regulatory and customs cooperation, underpinned by provisions ensuring a level playing field for open and fair competition as described below.
Zero tariffs, no fees, charges or quantitative restrictions across all goods sectors, with ambitious customs arrangements that build on the single customs territory provided for in the Withdrawal Agreement, respecting the Parties' legal orders.
Extent of the United Kingdom's commitments on customs and regulatory cooperation, including with regard to alignment of rules, to be taken into account in the application of checks and controls at the border.
In this context, recalling the Union's and the United Kingdom's intention to replace the backstop solution on Northern Ireland by a subsequent agreement that establishes alternative arrangements for ensuring the absence of a hard border on the island of Ireland on a permanent footing.
- 5. No-deal Brexit (Cliff-edge Hard Brexit)
Under this scenario, the UK will exit the EU on 29 March 2019 without a deal. This is the worst & most unlikely scenario because the No-deal Brexit does NOT have a majority within the UK Parliament (UK Commons).
Being based in both UK & EU27, Wellkang team can help you under all Brexit scenarios! Click here to contact Wellkang team now!
UK Rep: what is a UK Responsible Person (commonly known as UK Authorised Representative (Authorized Representative)) ?
A UK Authorised Representative (Authorized Representative) (officially so-called "UK Responsible Person") means a person (natural or legal person) established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the (non-UK) manufacturer’s obligations under UK regulations.
* The European Economic Area (EEA):
The EEA includes EU countries and also Iceland, Liechtenstein and
Norway. It allows them to be part of the EEA single market.
Switzerland is neither an EU nor EEA member but is part of the single
market.
For the purposes of CE Marking conformity and single market or UK market, references to EU countries should be read as references also to EEA states (incl. Iceland, Liechtenstein and Norway).
Click here NOW ! to learn more about the registration/notification procedures and official fees charged by the Competent Authorities in 30 EEA member states.
Authorised Representative Fees
Non-EEA manufacturers MUST appoint an Authorised Representative who has a registered business in EEA countries. The Auth Rep fees may vary depending on the level of services, knowledge & reputation of the firm, taxation of the country domiciled, etc. As a world-leading consultancy in CE marking, Wellkang is proudly present you with high-standard of services at competitive prices. Click here to view our Auth Rep fee list.
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