Following our earlier article on the subject, this article sets out the salient features of the most recent guidance on the regulation of medical devices in the event of a no-deal Brexit. In particular, we discuss the MHRA’s guidance of 26 February 2019 (Guidance) and the draft Medical Devices (Amendment) (EU Exit) Regulations 2019 (the Exit Regulations). The latter amends the Medical Devices Regulations 2002 (the UK MDR).

Earlier guidance

Earlier guidance revealed that the Government’s objective if there is no deal is to ensure that the UK has an effective standalone regime for the regulation of medical devices. In the interim, it intends to allow CE-marked devices to continue to be placed on the market in the UK. Provision has also been made for EU Regulation 2017/745 on medical devices (EU MDR) and EU Regulation 2017/746 on in-vitro diagnostic devices (EU IVDR) to come into effect in line with the transition periods established in the EU. The purpose of this is to ensure the newer rules in the EU and the UK (such as in respect of changes to classification of devices, and the introduction of a ‘person responsible for regulatory compliance’) are aligned.

Further guidance

The Guidance and the Exit Regulations reaffirm this position and establish the features and mechanisms required to effect it, including in the following key areas.

Manufacturers

The Commission has clarified that following a no-deal Brexit, the EU will not recognise UK-based Authorised Representatives.[1] Conversely, the Exit Regulations provide that any manufacturer not based in the UK (including those in the EU) must appoint a UK Responsible Person if they have devices on the UK market.[2] This Person must be physically located in the UK and capable of being contacted at any given time by the MHRA. The Responsible Person has a set of distinct regulatory obligations, including ensuring the declaration of conformity and technical documentation are available, acting as a liaison between the MHRA and the manufacturer and terminating the relationship with the manufacturer if the Responsible Person feels that the manufacturer has breached its obligations under the UK MDR.[3]

Notified Bodies and Conformity Assessment

As above, the Exit Regulations provide for CE-marked products to continue to be placed on the market in the UK for a limited period of time.[4] By extension, this entails the ongoing recognition of conformity assessments undertaken by EU-based Notified Bodies (including against the Medical Devices Directive 93/42/EEC and the EU MDR, once in effect).

In addition, the Exit Regulations establish an ongoing role for UK-based Notified Bodies, ensuring that certificates they have issued prior to 29 March 2019 will continue to be valid for the UK market (although these will not be recognised by the EU).[5] However, the Exit Regulations do not appear to empower UK-based Notified Bodies to undertake conformity assessments for new devices for the purposes of CE-marking following a no-deal Brexit, with the Guidance stating that if a manufacturer wishes to place a new device on the market in the UK with a CE-mark, they will need to obtain a conformity assessment from an EU-based Notified Body.[6]

Registration

The Exit Regulations dramatically expand the registration requirements for devices and IVDs. Whereas previously only a narrow class of devices needed to be registered with the MHRA, following a no-deal Brexit, the Exit Regulations require all devices and IVDs being placed on the UK market to be registered, regardless of whether they have also been registered in an EU-27 country.[7] This includes the registration of the person (manufacturer or Responsible Person) dealing in the device. In order to be registered as a UK Responsible Person, written evidence must be proffered to the MHRA that the manufacturer has given authorisation, which must be in the form of a headed letter or a signed contract. The Exit Regulations provide for a transition period to enable manufacturers to come into compliance with the new registration requirements. At this stage, this is set at 4 months for higher risk devices (such as Class III medical devices and List A IVDs), 8 months for medium risk devices (such as Class IIa medical devices and List B IVDs)  and 12 months for lower risk devices (such as Class I medical devices and general IVDs).

Data exchange

Following a no-deal Brexit, the UK will not have access to EU data systems, such as the European Databank on Medical Devices. Notwithstanding this, the Draft Explanatory Memorandum accompanying the Exit Regulations states that the UK intends to create a registration and data system that mirrors the changes to data storing and exchange in the EU, heralded by the EU MDR and EU IVDR.[8] The intent is for this to enable more expansive data to be captured and stored, including on incidents, clinical investigations and market surveillance activities.

Other interesting features: Shortages and the WTO

There are a number of other intriguing features included in the Exit Regulations which are not discussed in the Guidance. Standout among these is the ability for the Secretary of State to respond to serious shortages of medical devices by amending the application of the UK MDR through statutory instrument. The power appears to be limited to circumstances where the serious shortage, or potential serious shortage, is a consequence of Brexit and can only be exercised within two years of exit date.[9]

Another interesting insertion to the UK MDR is a power for the Secretary of State to designate a device or class of devices, which are approved in accordance with “equivalent” safety and quality standards as those in the UK MDR, or furnished with a conformity mark other than a CE-mark.[10] The Draft Explanatory Memorandum states that this is to provide the Secretary of State with the ability to ensure that World Trade Organisation obligations can be met, in the event there is no free trade agreement with the EU.[11] This would seem to have been introduced in order to cover the UK from a possible breach of the ‘most favoured nation rule’[12] which would require the UK to treat the EU (and products from there) in the same way as it would treat all trading partners that it does not have a free trade agreement with. This would potentially mean allowing products designated as compliant in other countries access to the UK market in the same manner as CE-marked products. This new power would ensure the Secretary of State had sufficient flexibility to ensure that this requirement was met if necessary.

Summary

The Exit Regulations and the Guidance set out a pathway which is highly aligned with the regulation of medical devices in the EU. Obviously, whether the UK will start down this path is contingent on both there being a no-deal Brexit and the draft Exit Regulations being passed (we understand that these are yet to come before the House of Commons). Even if these two eventualities occur however, there will be some remaining ambiguity in the regime; in particular, the duration of the ‘grace period’ in which CE-marked devices can be placed on the market has not yet been determined. It is also unclear what will replace it, such as the new UKCA mark[13], and what the criteria for affixing such a mark to medical devices and IVDs will be. As such, while the Exit Regulations and Guidance provide greater clarity, as with all things Brexit, much remains uncertain.