EU MDR – Where It Applies and Who Needs Representation

Introduction

Navigating the EU MDR can be challenging, especially for new manufacturers entering the European market. It all starts with understanding where the EU MDR actually applies and which representation requirements apply to your organization.

Some History – the Transition from MDD to MDR

The EU MDR represents one of the most significant overhauls in European medical device legislation in decades. It replaced the previous framework built on two key directives which had been in place since the 1990s:

The Medical Devices Directive (MDD 93/42/EEC)

The Active Implantable Medical Devices Directive (AIMDD 90/385/EEC)

This transition, officially effective from 26 May 2021, aimed to strengthen patient safety, improve transparency, and ensure better oversight of manufacturers and Notified Bodies across Europe. Unlike the old directives, which required each country to transpose rules into national law, the MDR is a regulation, meaning it applies directly and uniformly across all relevant European markets without the need for national legislation.

While most manufacturers are now familiar with the MDR’s technical and procedural requirements, its geographic scope often raises questions.

In which countries does the EU MDR actually apply?

The European Union (EU)

The MDR is a European Union regulation, meaning it applies directly and uniformly across all 27 EU Member States without the need for national transposition laws.

These countries are:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden.

The European Economic Area (EEA)

Beyond the EU, the MDR also extends to EEA countries — nations that are not EU members but participate in the single market through the EEA Agreement.

These are:

Iceland

Liechtenstein

Norway

These countries have incorporated the MDR into their national legislation, ensuring regulatory alignment with the EU.

Switzerland

Since May 26, 2021, the EU–Switzerland Mutual Recognition Agreement (MRA) has not been updated to include the MDR. Consequently, Switzerland is now treated as a “third country” under EU law.

This means that:

Devices imported from or into Switzerland require a Swiss Authorized Representative (CH-REP) or EU Authorized Representative (EU AR).

Manufacturers must comply with Swiss-specific requirements, governed by the Swiss Medical Devices Ordinance (MedDO), which closely mirrors but is independent from the EU MDR.

The United Kingdom

Following Brexit, the UK is no longer bound by the EU MDR.
However, the situation differs within the UK itself:

Great Britain (England, Scotland, Wales): Medical devices are regulated under the UK Medical Devices Regulations (UK MDR) 2002 (as amended). These currently align mostly with the old EU directives (MDD/AIMDD), though major updates have been and are being implemented. Devices placed on the Great Britain market must bear the UKCA mark and be registered with the MHRA. However, to support transition, CE-marked devices will continue to be accepted in Great Britain until 30 June 2028 for EU MDD/AIMDD compliant devices, or 30 June 2030 for EU MDR compliant devices, unless their certificate expires sooner.

Northern Ireland: Under the Northern Ireland Protocol, Northern Ireland continues to follow EU MDR requirements and recognizes CE marking for devices placed on its market.

Turkey

Although Turkey is not part of the EU/EEA, it maintains a Customs Union with the EU and has aligned its national legislation, introduced in June 2021, with the EU MDR. It mirrors the EU MDR’s structure and essential requirements.

In practice, though Turkey’s framework is closely harmonized with the MDR, manufacturers should however account for specific local administrative and language requirements.

Summary

Region	Countries	EU MDR 2017/745 applies?
EU Member States	27 EU Countries	✅ Yes
EEA Countries	Iceland, Liechtenstein, Norway	✅ Yes
–	Switzerland	❌ No (treated as third country)
United Kingdom (Great Britain)	England, Scotland, Wales	❌ No (UK MDR applies)
–	Northern Ireland	✅ Yes
–	Turkey	❌ No (national legislation aligned with MDR)

Representation Under the EU MDR: Authorized and Legal Representatives

Understanding where the MDR applies is just one part of the puzzle. The next step is knowing who must represent you within Europe, in case you are a manufacturer or sponsor of a clinical investigation based outside the EU.

Under the EU MDR (2017/745), there are two distinct roles depending on your company’s activity: the Authorized Representative and the Legal Representative.

The EU Authorized Representative (EU AR)

If a manufacturer is not established within the EU/EEA, they must appoint an EU Authorized Representative. This representative acts as the manufacturer’s legal presence within the Union and is the main point of contact for European authorities and Notified Bodies¹.

The EU AR ensures a non-EU manufacturer can legally place their device on the European market and maintain compliance throughout the device lifecycle.

The EU Legal Representative (EU LR)

When the sponsor of a clinical investigation is not established in the EU/EEA, they must appoint an EU Legal Representative (EU LR). This is not the same as the Authorized Representative, even though both roles serve as “representatives” within the EU.

The Legal Representative is responsible for:

Acting as the contact point for competent authorities, ethics committees, and study participants.

Being liable for the sponsor’s obligations under the MDR.

Being listed in the clinical investigation application.

This means that even if the manufacturer already has an EU AR, they will still need a separate EU LR if they conduct a clinical investigation in the EU. The same organization can potentially serve as both EU AR and EU LR if the entity meets the distinct MDR requirements for each role.

Note that some countries may choose not to require the establishment of a legal representative, provided that they ensure that the sponsor establishes at least a contact person on their territory.

A Special Case: When the Sponsor Conducts a Premarket Clinical Investigation

It is worth looking at a special case that often raises questions: clinical investigations with non-CE-marked devices.

When a manufacturer/sponsor wishes to conduct a study in the EU with a device that is not yet CE-marked, the usual rules for EU Authorized Representation do not apply in the same way.

The Authorized Representative under Article 11 MDR is required only when a device is being placed on the market or put into service within the EU. However, a clinical investigation is not considered “placing on the market.” The device is used solely for research purposes, not for commercial distribution.

As a result, during a premarket clinical investigation, only Article 62(2) of the MDR comes into play. If the sponsor is not established in the EU, they must appoint a Legal Representative established in the Union, but no Authorized Representative.

The Legal Representative covers the investigation phase, while the Authorized Representative becomes relevant only once the device enters the market.

Summary

Location	Manufacturer/ Sponsor	Activity	EU AR required?	EU LR required?
EU/EEA	Manufacturer and/or Sponsor	Placing device on EU market and/or conducting clinical investigation	❌ No	❌ No
Outside EU/EEA	Manufacturer	Placing device on EU market	✅ Yes	❌ No
	Sponsor	Conducting pre-market clinical investigation	❌ No	✅ Yes
	Manufacturer and Sponsor	Placing device on EU market and conducting post-market clinical investigation	✅ Yes	✅ Yes

Navigating EU MDR Requirements with confidence

Understanding where and how the EU MDR applies is essential for developing a compliant regulatory and clinical strategy. The framework’s complexity often lies not just in the rules themselves, but in how they interact across markets, roles, and responsibilities.

With our in-depth experience in EU regulatory requirements, clinical investigation planning, and EU MDR compliance, Franklyn Health helps manufacturers and sponsors translate regulation into practical pathways for success.

From early feasibility to full market approval, our experts provide tailored guidance grounded in European regulatory intelligence. We have supported both EU and non-EU manufacturers to navigate the complex EU regulatory frameworks and generate the clinical evidence they need to launch, grow and stay ahead.

Contact our team to discuss how we can help you plan and execute your EU MDR strategy.

Click here to book a call with our team of experts.

¹References:

Regulation – 2017/745 – EN – Medical Device Regulation – EUR-Lex

European Commission_New Regulations MD and IVD

European Commission_Transition Timelines from the Directives to the Regulations (MD and IVD)

EEA & Relations with the EU | European Free Trade Association

European Commission_Status of the EU-Switzerland Mutual Recognition Agreement for Medical Devices

Switzerland_Medical Devices Ordinance of 1 July 2020 (MedDO)

MHRA_Guidance Regulating medical devices in the UK

European Commission_EU-Turkey Customs Union Agreement for MD

Turkish Medicines and Medical Devices Agency_Announcement Amending Medical Device Regulations