Wind of Change. How Britain and Switzerland became third countries.

In this article, our authors Dr Ralf Hess and Dr Simon Schulz explain which new hurdles exist.

What the EU means by third countries.

According to the definition of the European Commission - Migration and Home Affairs, a third country is a country that is not a member of the European Union, as well as a country or territory whose citizens do not enjoy the European Union right of free movement, as in Art. 2(5) of Regulation (EU) 2016/399 (Schengen Borders Code).¹

So what do the UK and Switzerland have in common in terms of EU regulations?
Both countries are now considered "third countries". Seriously?

What made Switzerland a third country.

OK, for the UK it has been known for a long time that it will no longer be a member of the EU and that the economic and regulatory rules for third countries will apply without further treaty. However, Switzerland, which was thus never an EU member country, was "almost" considered an EU member country due to the International Framework Agreement (IFA) between the EU and Switzerland, and in detail for medical devices, the Mutual Recognition Agreement (MRA) allowed Swiss medical device manufacturers to automatically bring their CE marked devices to the EU market and vice versa. On 26 May 2021, the Swiss government ended the negotiations for the IFA in a unilateral decision.²

Both sides have criticised this decision. In any case, it significantly complicates trade relations between the EU and Switzerland. We will briefly reflect on the immediate consequences, the winds of change, for medical device manufacturers in the EU and Switzerland and the UK who intend to place medical devices on the respective markets and/or putting into service.

Switzerland and the EU.

Although Switzerland has never been a member state of the European Union, it has not been considered a "third country" from the point of view of EU regulation, mainly because of the "bilateral" MRA (Mutual Recognition Agreement) that has applied to EU equipment directives since 1 June 2002.³

With the new Medical Devices Act from 1 July 2020 (Medical Devices Ordinance (MepV), MedDO, (from 26 May 2021).⁴ "hybrid" regulations will apply to medical devices, which will certainly require an update of the currently existing MRA.

Directly applicable legal acts of the European Commission according to EU-MDR⁴ are:

For the purposes of applying this Regulation, the acts adopted on the basis of the provisions of the EU MDR listed above shall apply directly in Switzerland, in the respective version that is binding on EU Member States

Switzerland: A Third Country?

If the manufacturer of a medical device does not have its place of business in Switzerland, its products may not be placed on the market in Switzerland until an authorised representative in Switzerland has been appointed (Art. 51 para. 1 MedDO). This also applies to manufacturers with their place of business in the EU.⁵

The transitional periods pursuant to Art. 104a MedDO apply to the authorised representative:

1. if the manufacturer is established in an EU or EEA State or has authorised a person established in an EU or EEA State, he shall appoint an authorised representative in accordance with Article 51(1) for all devices placed on the market after 26 May 2021 within the following time limits:

1. For class III devices, class IIb implantable devices and active implantable medical devices: until 31 December 2021.
2. For non-implantable class IIb devices and class IIa devices: until 31 March 2022.
3. for class I devices: until 31 July 2022.2. For equipment and procedure packs, the appointment of an authorised representative in accordance with Article 51(5) shall be made by 31 July 2022.

...we have to get used to it...

The United Kingdom and Brexit.

The United Kingdom has withdrawn from the European Union with effect from 31 January 2020 and is therefore no longer a member state of the European Union. Furthermore, a distinction must now be made between Great Britain (England, Wales and Scotland) and Northern Ireland, as different regulations and transitional provisions apply to old and new medical devices.⁶

UKCA Mark and Conformity Assessment Bodies.

UKCA mark.⁷

"The UKCA (UK Conformity Assessed) mark is a UK product marking used for certain goods, including medical devices, being placed on the Great Britain market (England, Wales and Scotland). The UKCA mark is not recognized in the EU, EEA or Northern Ireland markets, so relevant products require a CE mark for sale in these markets.

Manufacturers can use the UKCA mark on a voluntary basis until 30 June 2023. From 1 July 2023, a UKCA mark will be required in order to place a device on the Great Britain market.

Where third party conformity assessment is required, a UK Approved Body is needed. However, Class I device and general IVD manufacturers can self-certify against the UKCA mark."⁷

CE marking and Notified Bodies in the UK.

As stated⁷ : "The UK will continue to accept CE marked equipment on the UK market until 30 June 2023. This applies to equipment that has been CE marked under and fully complies with the following applicable EU legislation:

• Directive 90/385/EEC on Active Implantable Medical Devices (EU AIMDD)
• Directive 93/42/EEC concerning medical devices (EU MDD)
• Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
• Medical Devices Regulation (EU) 2017/745 (EU MDR)
• Regulation 2017/746 on in vitro diagnostic medical devices (EU IVDR)

From 1 July 2023, new devices placed on the UK market will have to comply with the UKCA marking requirements. If there is currently a CE marking for a medical device based on self-certification, you can continue to do so and place your device on the UK market until 30 June 2023."

In order to place a product on the market in Great Britain (England, Wales and Scotland), manufacturers based outside the UK must appoint a responsible person who is resident in the UK. Not unexpectedly, Northern Ireland requires the authorised representative.^7,8

The EU MDR and EU IVDR in Northern Ireland.

Unlike the UK, the Medical Device Regulations (2017/745) and the In Vitro Diagnostic Medical Device Regulations (2017/746) will apply in Northern Ireland from 26 May 2021 and 26 May 2022 respectively, in line with the EU's timetable for implementation.⁹

Wind of Change.

The Wind of Change not necessarily implies a change to the better. Important trade relationships do exist between European medical device producers and producers in Switzerland and the UK. In a globalized world one might expect that compromises can be found “both” sites mutually benefit from and finally and most importantly for the benefit of the patient. We hope that this current state of trade relationships between Switzerland and the UK, politicians and companies find a way satisfying the patients’ needs in all markets.

References.

1. third country | Migration and Home Affairs (europa.eu), accessed 21 JUN 2021.
2. European Commission,(https://ec.europa.eu/commission/presscorner/detail/en/statement_21_2683), accessed 30 JUN 2021
3. MRA Switzerland - EU (admin.ch) accessed 29 JUN 2021.
4. SR 812.213 - Medical Devices Ordinance of 1 July 2020 (MepV) (admin.ch), accessed 29 JUN 2021
5. Swiss authorised representative (CH-REP) (swissmedic.ch), accessed 29 JUN 2021.
6. Regulating medical devices in the UK - GOV.UK (www.gov.uk), accessed 21 JUN 2021.
7. Op cit. 6.
8. Medical devices: EU regulations for MDR and IVDR (Northern Ireland) - GOV.UK (www.gov.uk), accessed 29 JUN 2021.
9. The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (legislation.gov.uk), accessed 29 JUN 2021.