Hard Brexit and medical devices, what happens from January 1, 2021
After a slowdown due to the Covid emergency, work is now intensifying in the EU to prepare for January 1, 2021, the end date of the transition period. From that moment onwards, UK will formally be a third country (just like the USA, Russia, China, India, etc.) and European law will no longer apply on its territory, with direct consequences for EU companies that market in UK and, vice versa, for UK companies intending to operate in Europe.
While, on the one hand, negotiations for the future collaboration continue (which have been taking place weekly since June 29, 2020 and can still change the scenario), on the other hand, Europe has begun to give guidance to companies to prepare for new relations with UK. In particular, on July 9, 2020 the European Commission issued the COM (2020)324 Getting ready for changes Communication on readiness at the end of the transition period between the European Union and the United Kingdom with which it highlighted the main sectors that will be affected by inevitable change.
Product circulation
As far as the circulation of products between the EU and UK is concerned, this Communication highlights the major changes to which attention should be paid. More precisely:
- all products exported from the EU to the UK shall comply with UK regulations and standards (and shall be subject to all checks and controls applicable to imports).
- similarly, all products imported from UK to EU will have to comply with EU regulations and standards and will be subject to all checks and controls applicable to imports
- EU companies currently distributing products from the United Kingdom will become exporters or importers of the products they place on the EU market (thus having to comply with the relevant obligations).
As far as product requirements are concerned:
- certificates issued by bodies based in the UK will no longer be valid for placing products on the EU market: consequently, where EU legislation requires certification by an EU notified body (as in the case of MDs), products certified by bodies based in the UK will no longer be allowed to be placed on the market.
- Where EU legislation requires the registration of products in databases (as for medical devices), it is possible that such registration must be made by the EU importer or by an authorized representative of the UK manufacturer.
- where EU legislation requires certain economic operators to be established in the Union, the establishment in the United Kingdom will no longer be recognised as fulfilling the requirement.
The UK Government is also active. In particular, on the website GOV.UK, on 1 September a specific Guide to market medical devices in UK “Regulating Medical Device from 1 January 2021” was published.
Content of UK Brexit Guide
It is worth pointing out that the information contained in the Guide only represents the position of the UK Government at the present time and will therefore only become effective once it is converted into law. The contents of the Guide are summarised below:
- from January 1, 2021 the Dm marketed in UK will have to comply with “The Medical Devices Regulations 2002”, legislation that is currently being amended to handle the exit from the EU and to align the requirements of the UK regulatory framework to the new requirements of the MDR.
- The manufacturer shall comply with the product marking and conformity assessment requirements for medical devices and IVDs, in accordance with the UK legal framework for Ukca marking.
- the competent authority for medical devices will be the Mhra (Medicines and healthcare products regulatory agency). This agency will designate the UK bodies authorized to carry out assessments for the Ukca mark.
- Manufacturers wishing to place a device on the UK market must first register with Mhra.
- If the manufacturer is not established in the United Kingdom, they shall designate a UK responsible person to register and act on their behalf.
Transition period for marking and registration
The Guide also foresees an additional transition period for the application of the new legal framework. More precisely:
Until June 30, 2023
From January 1, 2021 until June 30, 2023, medical device manufacturers can choose one of the following alternatives:
Marketing medical devices in the UK with the CE marking only
Until 30 June 2023 CE marking will still be recognized as valid in the United Kingdom. During this time, Ce certificates issued by European Notified Bodies will also continue to be considered valid and accepted in the UK. Therefore, until 30 June 2023 a MD manufacturer will be able to:
- comply with the requirements and procedures laid down in the applicable European legislation on medical devices (Directive 93/42/EEC or Regulation 2017/745)
- affix solely the CE mark on the product and
- market it both in Europe and in the UK.
To market DM in the United Kingdom with the Ukca marking
On January 1, 2021 the specific discipline for the affixing of the Ukca marking on the MD made in accordance with UK law will come into force. Consequently, from that date, a medical devices manufacturer who wants to place them on the market in the United Kingdom, can:
- follow UK internal regulations (Mdr 2022)
- affix the Ukca marking
- market Ukca-marked medical devices in the United Kingdom
It will not be possible to market medical devices that are only Ukca-marked in Europe, because this mark is not recognized by EU legislation.
After June 30, 2023
From June 30, 2023, medical device manufacturers will be able to:
market medical devices in the United Kingdom with Ukca marking only.
After the transition period mentioned above, medical devices will need to be Ukca-marked in order to be marketed in the UK. As highlighted above, this marking is not recognized as valid by the EU market.
market medical devices in the United Kingdom with CE marking and Ukca marking.
In this case, a double marking will be affixed to the product. The medical device must therefore comply with both EU (Reg. 2017/745) and UK (Mdr 2002) law. This will allow the medical device to be marketed both in the United Kingdom and in Europe. A (much shorter) transition period is also foreseen for the registration to the Mhra. More precisely:
- 4 months for Class III, IIb implantable MDs, and all active implantable MDs, which must be registered by April 30, 2021;
- 8 months for other Class IIb DMs and all Class IIa DMs which must be registered by August 31, 2021;
- 12 months for Class I DMs, which must therefore be registered by December 31, 2021.
The guide will apply in England, Wales and Scotland, while Northern Ireland will follow different rules (Protocol on Ireland/Northern Ireland).