The Member State and the EU MDR
The role of Member States in implementing the MDR
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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.
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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 Member States could determine how the requirements outlined in the MDD were implemented in their territory through enacting domestic legislation. In the UK, the MDD was implemented through Statutory Instrument 2002 No. 618, somewhat confusingly called “The Medical Devices Regulations 2002” - not to be confused with the MDR, or indeed any other EU Regulation.
The MDR - Medical Device Regulation (EU) 2017/745 - introduces 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 Member States in its entirety. Member States are no longer able to influence the means by which medical device legislation is brought into being in their territory. Once the MDR is fully implemented (now scheduled for 26th May 2021), medical device legislation will be fully harmonised across all Member States with no variance in methods of implementation.
How does the MDR affect Member States?
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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)
Is the UK still considered a Member State after Brexit?
The status of UK medical device regulation after the end of the current Brexit transition period is not yet fully concluded. From a pragmatic perspective it appears highly likely that provisions of the MDR will continue to apply - the medical device market is international and many manufacturers will have a presence in both the UK and the EU, meaning that drafting independent legislation would appear counter-productive. Furthermore, from a worldwide perspective, there is a trend towards a harmonisation of medical device regulatory standards. The MDR, as the most significant change in standards in this field, is likely to represent the comparative standard to which other systems will hold themselves in reference to.
In the absence of firm guidance to the contrary, it appears sensible to assume that the UK will continue to act as a Member State in upholding the provisions of the MDR. Even if that assumption eventually proves false, adhering to MDR standards will likely be sufficient to meet the requirements of any alternative legislation because the MDR is so broad and detailed in its provisions that requirements are unlikely to be higher or more stringent in any other system.