On 19 May 2020, the United Kingdom Government published draft negotiation documents (UK Positions) summarising its positions as regards the negotiation of a comprehensive Free Trade Agreement (FTA) with the European Union. These UK Positions, which had previously been available only to the UK negotiating team, articulate aspects of the overall proposals put forward by the UK Government to the European Commission in February 2020[1]. The UK Government is seeking a comprehensive FTA (such as that which the EU recently concluded with Canada[2]) without any sacrifice of legal or political sovereignty.

Since the EU has not accepted the UK Positions, this is simply the UK’s “wish list” for various regimes. As yet, the UK and EU are not even fundamentally aligned on the type of deal that would govern the future relationship between them. The EU has instead advocated a “level playing field”, arguing that a comprehensive FTA in the form proposed by the UK would be insufficient given the volume of trade and geographic proximity between the UK and the EU.

The UK Positions includes 114 pages of Annexes to a proposed Draft UK-EU Comprehensive FTA. Of particular interest to the life sciences industry are Annex 5-A[3] (Mutual Acceptance of the Results of Conformity Assessment) and Annex 5-D[4] (Medical Products).

This note addresses Annex 5-A insofar as it relates to Medical Devices, and identifies a number of potential shortcomings of the UK Position.

The new (or not so new) position

Annex 5-A applies to a number of categories of products regulated by technical regulations, including medical devices[5] and in-vitro diagnostic medical devices[6]. However, since Annex 5-A also applies to a number of other categories of goods such as “Toys” and “Pyrotechnics”, its contents are very general. Therefore, it does not give much colour to the arrangements that might apply in a complicated area such as medical devices.

Annex 5-A provides for the mutual recognition of “conformity assessment bodies” and “approvals” issued by them, provided that those bodies are accredited in respect of the relevant technical regulations. In the medical devices context, the relevant conformity assessment body is a Notified Body.

As we reported previously[7], the UK Medicines and Healthcare products Regulatory Agency (MHRA) had already stated that the UK would accept Conformity Assessments conducted by EU-27 Notified Bodies. While this guidance was withdrawn by the MHRA on 19 February 2020, most stakeholders believe that this will continue to be the position adopted by the UK Government, at least for an interim period.

In contrast, the EU position was that a Declaration of Conformity issued by an UK Notified Body would cease to be recognised in the EU. Accordingly, there is no obvious reason why a medical device manufacturer would seek a new Declaration of Conformity from a UK Notified Body.

There are currently two Notified Bodies for medical devices established in the UK[8]. Each of them has established a “sister” Notified Body in an EU-27 country[9]. It is widely accepted that virtually all medical device manufacturers who had appointed UK Notified Bodies have already “migrated” their technical dossiers to Notified Bodies established in the EU in preparation for Brexit.

Consequently, the primary focus of this particular UK Position will have little effect beyond the current UK position, assuming the UK intends to accept Conformity Assessments conducted by EU-27 Notified Bodies regardless (which seems extremely likely). Therefore, the only remaining work for the mutual recognition would be for the EU to recognise Declarations of Conformity issued by UK Notified Bodies. As mentioned above, it is highly unlikely that any such Declarations of Conformity will be issued, at least in the near term, due to the migration of dossiers to the EU.

A missed opportunity?

The UK Position does not request any substantive cooperation with the EU as regards medical devices. The European database on medical devices (EUDAMED) is a good example. EUDAMED forms a central role in the new European regulatory environment. However, the UK has not requested any form of mutual registration for products approved in the UK and products approved in the EU. This presents the prospect of double registration requirements for manufacturers seeking to operate in both markets. Another example is the lack of detail about cooperation at the higher regulatory level. The UK has not requested any involvement with the Competent Authorities for Medical Devices (CAMD) group, which promulgates significant guidance and ‘soft law’ for the sector. Further, given both the UK and EU intend to maintain attractiveness as life sciences markets, other key areas of alignment could have been sought, such as enabling the appointment of single authorised representative for both markets. As a consequence of this not being included in the UK Position, a manufacturer based in (say) North America or Asia would need to establish two representatives: one for the UK and another for the EU.

Consequences of cooperation

In addition to mutual recognition of conformity assessment bodies and their “approvals”, Article 11 of Annex 5-A seeks to establish cooperation on market surveillance, enforcements and safeguards. This is set in broad terms to prevent either the UK or EU taking more restrictive measures than the other in regards to devices. This epitomises a fundamental tension between the UK’s attempt to diverge from the EU’s legislative and regulatory framework for medical devices and yet still maintain mutual recognition and cooperation. In order for Article 11 to operate effectively, the UK’s legislation would need to closely mirror the EU regulatory framework. As a consequence, the UK would have to effectively remain harmonised to the EU framework without having the ability to contribute to policy, including through projects such as CAMD.

More for medicines

The UK Position in respect of medicinal products  is slightly more detailed than for medical devices. For example, they include mutual recognition specifically of Good Manufacturing Practice and provision for a working group to be established in regards to pharmacovigilance. However, this is a long way from a fully harmonised laws. We will address this is more detail in a separate note.

Summary

It appears that the UK has, so far, asked for very little of substance in relation to the medical devices sector. There appears to be a lack of ambition from the UK in securing involvement in policy (e.g. CAMD) or creating an aligned market for foreign entrants (authorised representative requirements, labelling etc.). By contrast, Switzerland, as a member of EFTA but not the EU, has been a part of CAMD and (at least intends at this stage) to participate in EUDAMED etc.

The UK Position does, however, potentially lay the groundwork for more meaningful alignment in the scenario where the UK does have a more independent regulatory system in the future. This seems quite far off, however. In the meantime, this UK Position forms the totality of the UK’s vision for a future relationship (especially since the MHRA’s earlier guidance on medical devices in a no-deal Brexit has been withdrawn). As such, our wider observation is that the UK Position on medical devices may represent a missed opportunity to foster greater collaboration between the UK and EU which, politics aside, is surely desired by all stakeholders: researchers, industry, clinicians, patient groups and regulators.

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[1] “The Future Relationship with the EU” published February 2020
[2] The EU-Canada Comprehensive Economic and Trade Agreement, also known as CETA.
[3] See here
[4] Ibid.
[5] As regulated by Regulation (EU) 2017/745, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
[6] As regulated by Regulation (EU) 2017/746 and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
[7] Medical Devices and No-Deal Brexit: where are we now? (20 March 2019)
[8] BSI Assurance UK Ltd and SGS United Kingdom Ltd.
[9] BSI Group The Netherlands BV in the Netherlands and SGS Belgium NV in Belgium.