Nov 10, 2020

Based on the current course of the UK’s planned withdrawal from the European Union by the end of 2020, an examination of how medical device market entry in Northern Ireland will be impacted is due.

In line with the Withdrawal Agreement, in which the European Union and UK set out the process of separation, the Brexit process is now in a stage where the UK has left the EU (January 31, 2020) and the transitional period started to allow for negotiations regarding a future trade agreement between EU and UK. This transitional period was planned to last for 11 months, with an option for the UK to ask for an extension of a maximum of two years. The UK did not use that option, so the transition period is currently set to end by December 31, 2020.

Along with the transitional period, the Withdrawal Agreement addresses the “special situation” in Northern Ireland. Northern Ireland, or The North of Ireland (the term often used in the Irish Republic) is part of the UK, but geographically part of Ireland. The Good Friday Peace Agreement regulates an open border, without checks, between both parts of Ireland. This means Northern Ireland remains partially in the EU, while at the same time part of the UK.

Placing devices on the Northern Irish market

In order to address the consequences of this “special situation,” the British government published guidance on the use of the UKNI marking. This is the marking needed for products placed on the market in Northern Ireland. This is regulated in sections 1, 2 and 3 of the Northern Ireland Protocol. UKNI marking is required if all of the following conditions are met:

  1. The product is placed on the Northern Ireland market after the end of the transition period;
  2. The product requires third party conformity assessment, like Notified Body certification for medical devices and IVDs;
  3. The product is intended to have its conformity assessed by a UK Approved Body after the end of the transition period.

This implies that if the product is placed on the EU market and/or you are planning to have the conformity assessed by an EU Notified Body, no UKNI marking is required. Self-certified devices also do not require UKNI marking; either CE Marking or UKCA marking will be accepted for either market.

In this context it is important to fully understand the following concepts:

  • “UK”: the abbreviation “UK” stands for the United Kingdom of Great Britain and Northern Ireland.
  • “Great Britain” refers to England, Wales and Scotland. Note: the Crown Dependencies (the “Bailiwicks of Guernsey and Jersey” and the Isle of Man) are not part of Great Britain.
  • “Placing on the market” means “the first making available in return for payment or free of charge of a new or fully refurbished device, other than a device intended for clinical investigation, with a view to distribution, use, or both, on the United Kingdom market(definition from the 2019 and 2020 amended Medical Devices Regulations 2002).”

Although it now looks as if a device placed on the UK market will also be considered as placed on the Northern Ireland market, it appears safe to assume that these geographical areas should be considered separately. It would be appreciated if this would be confirmed by additional guidance by the UK government.

“Qualifying goods”

In order to facilitate the special status of Northern Ireland, a special group of products has been defined: the “Qualifying Northern Ireland Goods,” or “qualifying goods” in short. These are either products processed in Northern Ireland, or products that have undergone processing operations in Northern Ireland and they were not at the time of processing under any form of customs supervision or restriction of control; or, they are so-called domestic goods. This basically means they are circulating freely on the Northern Ireland market, or they are available for such activity.

The following scenarios may apply, taking into account the conditions for requiring the UKNI mark, as well as the definition of qualifying goods:

Scenario

Marking

Placing devices on the Northern Ireland market, using an EU Notified Body

CE

Placing devices on the Northern Ireland market, not intended for the EU market, using a UK Approved Body

CE and UKNI

Placing devices on the Great Britain market (not Northern Ireland) until June 30, 2023

CE or UKCA

Placing devices on the Great Britain market (not Northern Ireland) from July 1, 2023

UKCA

Placing qualifying goods on the Great Britain market by a Northern Ireland manufacturer

CE or CE and UKNI

Placing goods on the EU market by a Northern Ireland manufacturer

CE

Note: Devices intended for the EU market cannot be UKNI marked.

Market surveillance issues

The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for market surveillance in the UK. This means currently manufacturers in Northern Ireland are under the supervision of the MHRA. It is not clear what will happen after the end of the Brexit implementation period.

On the one hand it would be unrealistic to assume the MHRA will be able to fully act as an EU Competent Authority because they are not part of the community of EU Competent Authorities. On the other hand, it will not be likely that the EU will accept free movement of devices on the Single Market if there is no level playing field for these manufacturers. A solution where the Irish Health Products Regulatory Authority (HPRA) would step in and thereby place UK citizens under EU rules is also not realistic.

Brexit means that somewhere between Brussels and London there must be a hard EU border. As it looks now like the Northern Ireland protocol creates a situation short of that hard border. This is a politically uncertain situation and the British government has already acted upon this by proposing the United Kingdom Internal Market Bill, which could place the hard EU border between Northern Ireland and the Irish Republic. The Internal Market Bill is seen as a potential breach of the Withdrawal Agreement, which is an international agreement. It has therefore met strong opposition, outside as well as inside the UK. As a consequence it can be expected that the political situation concerning Northern Ireland is far from stable. Manufacturers based in Northern Ireland may be best advised to focus on CE Marking now, and keep their options open for UKCA marking after June 2023.

Related UK and EU medical device regulatory resources from Emergo by UL:

  • UK REP and Brexit transition consulting for medical device manufacturers
  • European MDR preparation and compliance resource center
  • Whitepaper: How medical device companies can prepare for a no-deal Brexit

 

 

Author

  • Ronald Boumans

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