EU MDR Notified Bodies

What are Notified Bodies and how do they become MDR certified?

What are EU MDR Notified Bodies?

EU MDR Notified Bodies are organisations who have been designated by the EU Member State to assess medical devices and associated technical documents for conformity with the requirements of the EU MDR. If a notified body is satisfied that a device submission is in conformity, they have the right to issue a certificate of conformity allowing the manufacturer to affix a CE mark to the device and take it to market.

Article 35 of the MDR requires that all EU Member States who wish to establish MDR certified Notified Bodies must designate an authority to oversee the activity of designated Notified Bodies in their territory.

What is required of Notified Bodies designated under the MDR?

Chapter IV of the EU MDR contains a number of Articles detailing the law that legislates activities and scrutiny of Notified Bodies. Article 36 MDR requires that certified Notified Bodies have appropriate technical, scientific and clinical expertise permanently available in order to conduct their function. Where possible, such expertise should be employed by the notified body itself rather than on a contractor or consultancy basis.

Notified Bodies must submit a request for designation to the authority responsible for Notified Bodies in the Member State in which they are based. The application shall be assessed in accordance with provisions specified in Article 39 MDR.

Notified Bodies shall make available all relevant documentation, including the manufacturer’s documentation, to the authority responsible for Notified Bodies to enable its assessment, monitoring and surveillance activities.

How has Notified Body capacity been impacted by the MDR?

Before the enactment of the EU MDR there were around 96 certified Notified Bodies who were able to perform conformity assessments under the Medical Device Directive MDD 93/42/EC. Because the MDR requires that all Notified Bodies designated under MDR undergo a fresh assessment, there has been a marked reduction in overall notified body capacity. Some Notified Bodies have chosen not to pursue accreditation against the MDR, while others have been delayed in gaining approval as MDR certified.

Current statistics show that there are 13 MDR certified Notified Bodies fully approved under the MDR. A further 12 have their applications currently pending.

What specific tasks do Notified Bodies perform when assessing a medical device submission?

MDR Notified Bodies perform a number of tasks while performing a medical device conformity assessment, each relating to an aspect of the submission from the medical device manufacturer. Furthermore, each notified body will need to perform “maintenance tasks” for CE-marked devices, including scheduled and unscheduled site audits.

The complexity and depth of different tasks will vary according to the risk class of the medical device in question but can be simplified into the following overview:

  • Assessing manufacturer’s Quality Management System (QMS)
  • Assessing the medical device and the device history file
  • Assessing a range of technical documentation in line with requirements in Annex II and Annex III MDR
  • Performing an assessment of the Clinical Evaluation Report (CER) summarising the clinical evaluation of the medical device

The overall objective of the assessment process is to ensure that the device has been developed in line with MDR requirements and within a quality management framework sufficient to ensure that quality will be maintained throughout the device lifecycle. The notified body will also need to assess whether conformity with all relevant Annex I General Safety and Performance Requirements has been demonstrated through clinical evidence.

Where can I find a list of designated EU MDR Notified Bodies?

A list of EU MDR certified Notified Bodies can be found in a number of different places. The most authoritative list is probably that on the EU Commission website; this site maintains an updated list of Notified Bodies designated under MDR.

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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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