Impact of Brexit on Medical Devices’ Stakeholders in a No-Deal Situation

  1. Signifying EU 27 After Brexit

The UK has been making efforts to disengage itself from the EU membership ever since the 2016 referendum, and now there is a likely prospect it will crash out soon by the end of this year without a deal prepared to suffice all stakeholders in the EU and UK. With the United Kingdom composed to withdraw from the EU, discussions are happening about what future trade and regulatory affairs between the EU and the UK will come up. While many players expect that a joint beneficial Brexit contract will materialize for the medical devices industry, but these are just expectations up-till now.

Experts were thinking and opinion makers were writing that something big was coming in October 2019, but the situation did not unfold any further. In-fact; now the news stories are coming that says from 1st January 2021, the way of trade between the EU and UK will drastically change. Therefore it is important for the private and public parties in the medical devices sector to get themselves prepared for the high possibility when no such deal is made. Therefore a situation for No Deal Brexit Medical Devices is also not out of scope in current scenario. What could this result for the medical device industry in Europe, and how the businesses in UK needs to prepare for that?

This piece will empower you to comprehend the impact of Brexit on medical devices’ economic operators which includes distributors, importers and manufacturers and how in a no-deal situation they must prepare.

It’s still worth mentioning that the present timeline is an extended version of 30th March 2019. Now the transition period may not further extend after the end of 2020. Anyway, businesses should start getting immediately prepared.

Distributors & Importers in the United Kingdom

Presently, countries situated outside of the EU are reflected as “third countries.” Economic operators who source products from a third country on the European market are known as the importers and must fulfill with definite Union legislation requirements that vary from those relevant for medical products sourced within the European market.

After the UK’s official removal from the EU, the UK will be treated as a third country for the European market and all of the same regulations that apply to other countries will apply them as well. At that point of time, economic operators who were earlier operating as distributors from UK will now be opting as importers and will have to comply with all importer requirements.

This may also have extended outcomes on UK distributors taking off their EU-based standing since the Product Liability Directive 85/374/EEC enforces product liability with the importer.

Preparation Steps in a No-deal Situation for UK Distributors:

  • Consider the possible effects of the Product Liability Directive 85/374/EEC and how you should prepare for that for continuing business in Europe.
  • Build your understanding of the major dissimilarities between regulations influencing distributors and importers and how they apply to your business and devices.

Manufacturers & Authorized Representatives in the United Kingdom

Medical device manufacturers situated in the UK will essentially be needed to select an authorized representative within the European Union which is a requirement for all economic operators operating from outside of the EU.

Till the transition period, this will allow UK-based authorized representative who aspire to remain introducing specific medical devices on the European market, including both the medical devices and In-vitro diagnostic device (IVDs). Manufacturers reliant on UK-based authorized representatives are advised to contract out with other representatives in the European market (outside of UK) before the UK rolling out from the EU.

The MHRA (Medicines and Healthcare products Regulatory Agency) of the UK will also develop special requirements for non-UK medical device manufacturers and distributors exporting goods to the UK. Therefore the EU Economic Operators will need to prepare for that. But up-till now such requirements have to unfold. But since in the EU, the MDR and other EU regulations are already there, therefore a simulation study of a no-deal situation is possible.

Preparation Steps in a No-deal Situation for Manufacturers in UK, and for Manufacturers who have authorized Representatives in UK

  • Manufacturers based in the UK must develop an authorized representative within the Europe (excluding UK).
  • Outside EU Manufacturers with an authorized representative in the UK must select an authorized representative within the Europe (excluding UK).

EC Certification by a UK Notified Body

When the UK withdraws from the EU, UK Notified Bodies will no more be reflected as EU Notified Bodies. In other terms, the UK Notified Bodies be erased from the European Commission’s NANDO (New Approach Notified and Designated Organizations) information system database and will no longer be qualified for conformity assessment responsibilities relating to European Union product legislation.

Moreover, all EC certificates delivered by UK-based notified bodies could also be considered null and void as the result of withdrawal impact. This will possibly impact manufacturers globally who presently depend on Notified Bodies in UK. Therefore Economic operators residing outside the EU or in the UK needs to make sure that they have valid certificates allotted by any of the EU country Notified Body (other than the UK) before the withdrawal impact or otherwise they can be vulnerable and their products placement on the European market is at stake.

Operators having those certificates released by a UK Notified Body should opt for a new certificate or manage a certificate transfer so as to ascertain that they remain complying all EU-led conformity procedures.

Preparation Steps in a No-deal Situation for EC Certificates issued by UK-based Notified Bodies

  • Manufacturers having their EC certificates delivered by UK-based notified bodies must acquire new certificates delivered within the countries of the European Union other than UK, or manage a relocation of present certificates to any of the EU-27, before the possible impact of UK’s withdrawal.

The Management of Brexit in a No-deal Situation

While the accurate impact of the UK’s removal from the EU is yet to be seen, the most possible consequences are added costs for compliance both for UK-based economic operators who want to market their devices on the European market and the EU-based economic operators who want to export devices to the UK. But, with adequate and timely planning and preparation in the areas highlighted above, the unintended outcomes can be minimized.

TS Q & E is present in multiple countries in the Europe which includes Switzerland, Italy and others. TS Q & E can offer relevant help for the economic operators in the UK and those who are reliant on UK-based authorized representatives or notified bodies. TS Q&E cannot only serve you as a European Authorized Representative but can also support you in liaison with a notified body in EU and offer consultancy to get you EU-based EC certificate.

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.

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