The Member State and the EU MDR

The role of Member States in implementing the MDR

Member States and medical device law

An EU Member State is any European country that is a signatory to The Treaty of The European Union. Member States, through signing the Treaty, agree to abide by the principles of free movement of goods, services and people, and submit to the authority of the European Parliament, The Court of Justice of the European Union, and the European Commission.

European legislation, in its various forms, seeks to enforce unified standards across the Union and lay a consistent foundation to underpin the free movement concept.

The EU enacts three major categories of legal instrument that affect Member States in different ways:

• Directives are legal acts that have universal applicability but do not normally take direct effect. They are brought into law in each Member State through the enactment of domestic legislation, allowing a degree of flexibility and domestic interpretation into the manner in which the required outcome is brought about.
• Regulations take direct effect, outlining both the objective to be achieved and the manner in which its achievement must be brought about.
• Decisions take direct effect and are binding on the specific groups of individuals to whom they are addressed.

Up until the introduction of the MDR, medical devices were regulated by Medical Device Directive (MDD) 93/42/EC. As described above, this meant that through enacting legislation Member States had some control over how the MDD was interpreted in their territory. In the UK, the MDD was implemented through Statutory Instrument 2002 No. 618, somewhat confusingly called “The Medical Devices Regulations 2002” or UK MDR (2002) - not to be confused with the EU MDR.

The MDR - Medical Device Regulation (EU) 2017/745 - introduced a number of significant changes from the MDD, not least of which is the form of legislation itself. As suggested by the name, the MDR is a Regulation rather than a Directive and therefore takes direct effect in EU Member States in its entirety. The MDR is intended to fully harmonise rules for regulating medical devices across all Member States.

UKCA: The UK and EU MDR post-Brexit

The obvious exception in the UK. As the MDR implementation date fell after the date of Brexit, the EU MDR did not take direct effect in the UK. Accordingly, the UK MDR (2002) remains in force. Transitional arrangements - with updates to timeline extensions posted by the Medicines and Healthcare products Regulatory Agency (MHRA) - currently allow for devices CE-marked under EU MDR to be legally marketed in the UK without a UKCA mark, meaning manufacturers can avoid dual certification at present. A UKCA mark currently only enables device sales in Great Britain.

How does the MDR affect Member States?

The MDR outlines a number of responsibilities for Member States alongside its provisions that apply to medical device Manufacturers, Notified Bodies, and other economic operatives within the medical device industry.

Provisions that apply directly to Member States include:

• Article 101 that requires all Member States to designate a Competent Authority to appoint Notified Bodies and oversee medical device safety in their territory.
• Article 93, mandating that Member States perform market surveillance through their competent authority
• Article 89, requiring Member States to centrally evaluate any serious incidents that have occurred in their territory
• Article 87, instructing Member States to undertake targeted information campaigns to encourage healthcare professionals, medical device users and patients to report any serious incidents to the Competent Authority
• Inform other Member States if a Member State authorises the use of Article 59 to derogate from standard conformity assessment procedures
• Article 92 that requires Member States to contribute to the setting up of an electronic system on Vigilance and Post-Market Clinical Follow-up (PMCF)