The Northern Ireland Protocol & Medical Devices: Explained
How will the Northern Ireland Protocol impact companies in the medical devices sector? That is a question that we have been asked many times in recent months. Now, as the UK’s departure from the EU gets closer, we have created a brief guide on the Northern Ireland Protocol for medical device companies and distributors. The guide answers some of the most commonly asked questions that we have received by email in recent weeks.
This article is part of our extensive Brexit coverage. You can access all of our Brexit articles, e-books, and guides by clicking here.
This article answers:
- What Is The Northern Ireland Protocol?
- Why Is It Being Introduced?
- What Impact Will the Northern Ireland Protocol Have On the Medical Devices sector?
and finally, we offer our advice on how you and your company can best manage the situation.
What Is The Northern Ireland Protocol?
“The Northern Ireland Protocol necessitates checks and customs controls on goods entering Northern Ireland from Great Britain. To a lesser extent, it necessitates some controls on goods leaving Northern Ireland and going to Great Britain. The exact extent of both such checks and controls are to be agreed in an EU UK joint committee in the course of 2020”. (Source: BrexitLegal.ie)
Under the terms of the Protocol, Northern Ireland remains bound by EU single market rules for:
- Product requirements and safety, including chemical and medicinal safety
- Animal and plant health welfare
- Food safety and standards for animal products
- Farming standards
Why Is It Being Introduced?
Brexit has brought significant changes to the UK and EU trade agreements. These changes increased the risk of the reintroduction of a ‘Hard Border’ between Ireland and Northern Ireland, however, the reintroduction of a hard border could potentially lead to political instability.
In December 2017, the UK and EU committed to ensuring that there would be no physical checks or infrastructure on the island of Ireland. However, this proved difficult to do while maintaining the integrity of the EU single market and allowing the UK the freedom to have a clean break from the EU. The EU proposed a Northern Ireland-only backstop where NI would remain in the EU’s customs territory and align with EU single market rules, but this was rejected by the then Prime Minister.
The protocol was re-negotiated by Prime Minister, Boris Johnson in October 2019 and was made part of the withdrawal agreement for the UK leaving the EU on 31st of January 2020. The ‘Protocol on Ireland/Northern Ireland’ requires custom and regulatory alignment between the EU and Northern Ireland only.
The protocol means that goods will not need to be checked along the Irish border, between Northern Ireland and the Republic of Ireland, when the new UK-EU relationship begins, on 1 January. Northern Ireland will remain part of the UK customs territory but must align with the EU customs regulations. However, to comply with EU requirements, checks will be required on certain goods entering Northern Ireland from Great Britain (England, Scotland, and Wales), thus creating a regulatory and customs border in the Irish sea.
Currently, as part of UK-EU trade talks, tariffs (taxes on imports) may be charged on goods “at-risk” of moving from Northern Ireland into the Republic of Ireland as Ireland remains in the EU. A joint committee of UK and EU government officials will determine if goods are at risk of onward movement to the EU.
Will the MDR & IVDR Apply in Northern Ireland?
Yes. The introduction of the MDR was delayed until May 26th, 2021. The IVDR will be introduced on May 26th, 2022. Both will come into force in Northern Ireland on their respective introduction dates.
If the Covid-19 related delay to MDR had not occurred, the MDR would have come into force in the UK on May 26th, 2020 and, as a result, would have become law in the UK along with all other EU retained laws on January 1st, 2021. Therefore, EU MDR 2017/745 will not come into force in Great Britain, and the medical device sector will need to adhere to Directive 93/42/EEC. In the UK, the Directive is, confusingly, labelled Medical Devices Regulations 2002 (SI2002 No. 618, as amended) and is referred to as UK MDR.
CE, UK CA & Other Marks on Medical Devices
The UK is introducing its own conformity mark, the UK CA, on January 1st, 2021. A CE mark will still be needed for devices placed on the Northern Ireland market and EU rules will need to be met.
Mandatory conformity assessments carried out by UK Notified Bodies will no longer be recognised by the EU after January 1st, 2021. Companies impacted by this will need to use an EU recognised Notified Body to carry out their mandatory third-party conformity assessment if they wish to CE mark a device.
Devices that have a self-certified CE mark will be able to continue to supply their product in the Northern Ireland market.
The MHRA, in its September 2020 guidance, stated that “UK Approved Bodies will be able to conduct conformity assessments for the purposes of the Northern Ireland market as follows: for medical devices, active implantable medical devices and in vitro diagnostic medical devices under Parts II, III, and IV of the UK MDR 2002 (in the form in which they exist in Northern Ireland). Where a device has been assessed by a UK Approved Body, the UK(NI) mark will accompany, but not replace, the CE mark. Products carrying both the CE mark and the UK(NI) mark cannot be placed on the EU market”.
Devices placed on the Northern Ireland market with a UK CA mark must be accompanied by either a CE mark or a CE UK (NI) mark.
Do I Need an EU Authorised Representative for Northern Ireland?
Northern Ireland will adopt the MDR in May 2021 and the IVDR in May 2022. The new regulations specify that companies must appoint an EU Authorised Representative to act on their behalf.
Is There a UK Equivalent of the EU Authorised Representative for Post Brexit UK?
The UK equivalent of the EU Authorised Representative will be the UK Responsible Person. From January 1st, 2021 the manufacturer will need to designate a UK Responsible Person that has a registered place of business in the UK if the product is manufactured outside of the United Kingdom. There are several grace periods in place for the appointment of UK Responsible Persons and they are listed below.
Registering a Product on the Northern Irish Market
Most devices, IVDs, and custom devices will need to be registered by January 1st, 2021 to be sold on the Northern Irish market. There are exceptions, as outlined in the box on the previous page.
What Should I Do If I Am A Manufacturer Based in Northern Ireland?
You will need to register your device with the MHRA. This applies to all classes of device and custom devices.
If We Release A Medical Device Within The UK Prior To December 31st, 2020 And The Goods Remain In The UK, Can We Still Ship-To EU After January 1st, 2021 Without The EU AR Info On The Artwork?
The short answer to this is ‘No’.
The MHRA has stated that devices placed on the Northern Ireland market after December 31st, 2020 will need to have an EU Authorised Representative listed on the labelling to meet EU labelling requirements. The MHRA guidance on the issue can be read by clicking HERE. The EU guidance on the issue can be read by clicking HERE. Page 6 of the EU guidance document states:
The changes described….will not apply with respect to trade between the EU and Northern Ireland, where the Protocol on Ireland and Northern Ireland, which is an integral part of the Withdrawal Agreement, will apply as of the end of the transition period, alongside any that is produced regarding an agreement on a future partnership. In accordance with that Protocol, Union rules relating to goods (including fiscal rules, indirect taxation, and non-fiscal rules) and the Union Customs Code will also continue to apply to and in Northern Ireland.
We Can Help You To Navigate Brexit Related Changes To Your Business
We are assisting many companies at the moment with issues relating to Brexit. We are providing consultancy support to companies in the UK, EU and elsewhere to enable them to navigate the changes that Brexit will bring about.
You can contact us by completing the form below, by calling us on 00353 52 61 76706, or by email: email@example.com
Further Brexit & Medical Device Related Articles
Does your company currently have an EU Authorised Representative that is based in the United Kingdom? If so, your company will have to consider moving EU Authorised Representative very soon to ensure that you have representation with the European Union once the UK leaves the European Union. Acorn Regulatory can assist you in moving your EU Authorised Representative from the UK to Ireland. The result of the December 12th, 2019 election saw the Conservative Party win an overwhelming majority, having campaigned on the slogan ‘Get Brexit Done‘. Read More Here.
Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s. There is a transition period for the implementation of the various elements of the new regulations, with MDR becoming fully operational in May 2020 the IVDR in May 2022. Read More Here.
You can read our full collection of Brexit articles and whitepapers by clicking here.