Brexit Agreement: Reset your clocks!
Regulatory Updates | Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- European and UK negotiators strike a deal
- Transitional period until 31 December 2020: 21 months extra
- The MDR will apply in the UK; it is likely this will also happen for the IVDR
- A mutual agreement would enable movement of medical devices between the UK and EU, but whether this is politically achievable remains unknown
Negotiators discussing how the UK will leave the European Union have reached a draft Withdrawal Agreement about the transition period. The transition will start on March 29, 2019 and will end on December 31, 2020. Instead of 12 months from now, there are 21 months to prepare. This is still a limited time, so medical device companies should reset their clocks and keep vigilant for the consequences of Brexit.
This draft agreement must now go through the British Parliament and be accepted by the European Member States. The agreement sets out the terms of how the separation will take place. The draft agreement has 130 pages with sections highlighted in green (agreed at negotiators’ level), yellow (political objectives) or not highlighted (proposed by the EU, with ongoing discussion). It addresses many questions, although not all in detail.
The agreement mentions a transition period, but it is not totally clear what this means. The EU negotiators are clear in what they want: the UK should follow EU rules without being involved in rule making, and the free movement of goods, people and money should continue and remain subject to the European Court of Justice. To hardline Brexiteers this looks very much like a prolonged stay in the EU, but this time with no political say for the UK. However, British and European negotiators agree that business should have to adapt only once to the changes. So either at the start or at the end of the transition period, businesses need to make the necessary changes.
Implications for medical device manufacturers
The Withdrawal Agreement has made provisions regarding medicinal substances (art. 41 and 56). No specifics are mentioned regarding devices. The Withdrawal Bill (HL Bill 79) states in article 3(1) that EU legislation that is applicable on Brexit day will become part of UK law.
The Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) will not yet be applicable on Brexit day. However, the transition agreement states in article 122.1: ‘Union law shall be applicable to and in the United Kingdom during the transition period.’ With the Date of Application of the MDR, this implies that this EU legislation will become UK law as well. This will not work for the IVDR as that Date of Application is in 2022. However, I expect British law makers will ensure the IVDR will also be applicable.
This would result in the following situation: The UK would become a non-EU market, not recognizing the EU Court of Justice, but British industry would manufacture medical devices and IVDs in compliance with European requirements. Where this will lead to for the medical device industry is far from clear, but the scenario below represents the best possible outcome:
- There will be a mutual recognition agreement between the UK and the EU for medical devices and IVDs. This will enable movement of devices between both markets without the need for an Authorized Representative.
- Notified Bodies can remain in place and they will be able to issue certificates.
- The current Competent Authority in the UK, MHRA, will remain in its supervising position and will continue exchanging information with other Competent Authorities and the European Commission regarding safety and public health risks related to devices.
But this ideal solution would come at a price: UK companies will have to accept the authority of the European Court when it comes to the interpretation of the law, without any negotiating power regarding those laws. This is not what the Brexiteers had envisaged and therefore it will remain unclear exactly what will happen with medical devices after Brexit.