The Member State and the 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 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 MDR 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?

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 global 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.

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Powerful PMCF systems for your MDR compliance

PMCF registries and plans for your medical devices designed by our MDR experts.

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  • Real-time data collection

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MDR Consulting

Our team of MDR professionals are medical device regulatory consulting specialists offering tailored MDR compliance services.

MDR Training

Our comprehensive training services are delivered by experts and address all aspects of MDR compliance.

Who we work with

Our clients come from across the industry and range from pre-start businesses to stockmarket-listed multinationals. We also have key strategic partners based in the UK and Denmark.

  • It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.

    CEO, EU medical software company
  • Your service surpassed our expectations and added value across our organisation. We now feel much better placed to prepare for the MDR.

    Chief Executive, MedTech pre-start
  • A comprehensive, detailed and highly professional service.

    Regulatory Manager, UK device manufacturer
  • International

    We work with medical device manufacturers based in the UK, Europe, the US and Asia, developing MDR strategies for both physical devices and software as a medical device.

  • Diversified

    Working with us gives you access to our growing international team of MDR-trained healthcare professionals from a wide variety of clinical backgrounds.

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We have compiled some of our frequently asked questions. If you'd like to know anything else about what we do, feel free to ask us a question.

  1. We can work with the majority of medical device manufacturers seeking compliance of their devices in accordance with Medical Device Regulation (EU) 2017/745, including both hardware and software devices. We also offer a free, no-obligation consultation, so please feel confident about discussing your requirements with a member of our team.

  2. No. We will work with you to produce systems and to support your EU MDR compliance, but we do not conduct research ourselves. We will provide tools for you to conduct your own Post-Market Surveillance. Our range of services are designed to assist you in this matter.

  3. Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice. We also comply fully with the requirements of GDPR.

  4. Our medical device regulatory consulting is built around a strict quality framework and we only work with clients who share this commitment to quality. Our CEO is a medical doctor with years of experience in the medical device industry and assumes personal responsibility for every project. Our product development process integrates client feedback throughout product production, ensuring a constant focus on your needs.

  5. We work with clients of all sizes and at all stages of their regulatory compliance journey. Our team are here to help and are happy to respond to general enquiries, even if you don't feel like you know where to start. We are experts at 'tuning in' to your requirements and will guide you through the entire process. Our free MDR Compliance Guide and suite of MDR downloads stand as proof of our commitment to help you understand your obligations under the MDR.

  6. Yes. Software as a Medical Device is an increasingly-important segment of the medical device market. We have extensive experience in building regulatory systems for medical software and offer a special application of all our MDR services for software products. We also offer unique downloads and white papers that focus specifically on Software as a Medical Device.

  7. At its core, working with the MDR is about working with clinical evidence. Whether you need to generate evidence for PMCF, analyse data for writing a CER, or build an MDR-ready PMS system, our medical experts have the clinical acumen to ensure that your clinical evidence is produced and interpreted with the highest levels of professionalism. Medical professionals work with clinical evidence all day. We bring their specialist capabilities directly to your MDR strategy.

  8. We believe in transparency and aim to build long-term relationships with our clients. This commitment is demonstrated by our customer-focused pricing strategy. You pay a small deposit upfront, only paying the balance when the work has been completed to your total satisfaction. For higher-value projects we offer flexible payment packages on an individual basis — please contact a member of our team to find out more.

  9. Yes. Our unique business model allows us to scale to accommodate almost any amount of work. Many of our medical professionals remain clinically active, meaning that we have trained more than we presently need. This system allows us to have ready availability of redundant capacity that can be called upon in the event of a surge in demand. Whatever your requirements, our unique business model allows us to step in faster than any of our competitors.

  10. Yes. We run a number of events throughout the year focusing on specific aspects of MDR compliance. We also offer a limited number of free webinars on a limited basis — subscribe to our newsletter to be notified early when we publish new events. Of course, we also have our extensive MDR Compliance Guide and free MDR downloads suite, both of which offer extensive training on all aspects of MDR compliance.

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