Medical Device Regulation MDR (2017/745) Status 2024

Manufacturers who wish to place medical devices on the market in the EU must comply with the European Medical Device Regulation MDR.

This Regulation (EU) 2017/745 on Medical Devices, as it is officially titled, also imposes requirements on notified bodies, distributors, importers, and health institutions such as hospitals.

1. Overview of the MDR requirements

1.1 Requirements for manufacturers and their medical devices

The requirements that the Medical Device Regulation places on manufacturers are extensive.

1.1.1 Cross-product requirements

Requirements of the MDR and links to articles	Explanation
Quality Management System	All manufacturers require a QM system for developing, producing, and monitoring devices on the market, among other things. Except for class I devices, certification is usually also required.
Risk Management System	Risk management must ensure that the benefits are acceptable in view of the risks throughout the entire product life cycle.
Person Responsible for Regulatory Compliance (“PRRC”)	Manufacturers are obliged to employ a Person Responsible for Regulatory Compliance who ensures, for example, that the technical documentation is prepared in accordance with their own QM system and in compliance with the MDR.

1.1.2 Product-specific requirements

Requirements of the MDR and links to articles	Explanation
Device Classification	The manufacturer must determine the risk class for each device.
General Safety and Performance Requirements and Technical Documentation	The technical documentation must meet the requirements of Annex II and provide all evidence that the general requirements of Annex I are fulfilled. For this evidence, manufacturers are expected to apply harmonized standards and applicable common specifications.
Clinical Evaluation	As part of the clinical evaluation, the manufacturer must continuously check whether the devices’ safety, performance, and benefits are given. If the clinical data is not sufficient, a clinical investigation is necessary.
Unique Device Identification (UDI)	All medical devices must be given a Unique Device Identification, the UDI. This also means that the devices must be registered in EUDAMED.
Labeling	The MDR precisely defines requirements for instructions for use, other accompanying materials, and labeling such as product labels and packaging.
Conformity Assessment	Depending on the risk class of the device, manufacturers must undergo a conformity assessment procedure. Except for class I devices, they must involve a notified body. If successful, manufacturers must prepare a declaration of conformity and affix the CE mark.
Post-Market Surveillance and Vigilance	Manufacturers are obliged to monitor their medical devices on the market throughout their entire lifecycle , continuously collect respective data , and take corrective actions if necessary. If there are negative trends related to incidents, they must inform the authorities.

1.2 Requirements for other stakeholders (distributors, importers, etc.)

Not only medical device manufacturers must comply with the Medical Device Regulation, but also other stakeholders:

• Requirements for distributors
• Requirements for importers
• Information for hospitals and other operators
• Requirements for manufacturers of specific devices without an intended medical purpose (Annex XVI devices)

2. Organization and structure of the MDR

The Medical Device Regulation comprises 123 articles divided into 10 chapters. It also has 17 annexes.

2.1 The chapters

The Medical Device Regulation (MDR) has been completely restructured compared to the old Medical Device Directive (MDD):

Chapter number With links to MDR	Title / Content / Requirements With links to articles
I	Scope of application and definitions
II	The most important requirements for manufacturers, distributors, importers, and member states. Many references to articles in other chapters and the annexes
III	Traceability of devices, especially requirements for UDI
IV	Requirements for notified bodies
V	Classification and conformity assessment procedures
VI	Clinical evaluations and clinical investigations
VII	Post-market surveillance, market surveillance, reporting
VIII	Cooperation between member states, MDCG, and other experts
IX	Confidentiality, data protection, penalties
X	Transitional periods and more

2.2 The annexes

The MDR has 17 annexes.

Annex number With links to the MDR	Title / Content / Requirements With links to further information
I	General safety and performance requirements
II	Technical documentation
III	Technical documentation for post-market surveillance
IV	EU Declaration of Conformity
V	CE marking
VI	UDI, EUDAMED
VII	Requirements for notified bodies
VIII	Classification rules
IX to XI	Conformity assessment procedure: – Complete QM system – Type examination – Product conformity verification
XII	Certificates from notified bodies
XIII	Custom-made devices
XIV	Clinical evaluation
XV	Clinical investigation
XVI	Devices without an intended medical purpose
XVII	Correlation table

3. Further articles and links

3.1 Further articles

The EU has postponed the transitional periods for the application of the MDR several times. The rules are so complex that an article on the transitional periods is helpful.

Further explanations and requirements have been published by the Medical Device Coordination Group (MDCG).

There are different requirements for devices without an intended medical purpose (“Annex XVI devices”).

3.2 Further links

• MDR (original text)
  • English (HTML) linked version of the Johner Institute (consolidated)
  • English (HTML) Original version of the EU
  • English (PDF) Original version of the EU
  • German (HTML) linked version of the Johner Institute (consolidated)
  • German (HTML) Original version of the EU
  • German (PDF) Original version of the EU
• Corrigenda
  • 1st Corrigendum: REGULATION (EU) 2020/561 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  of 23 April 2020
  • 2nd Corrigendum: COMMISSION DELEGATED REGULATION (EU) 2023/502 of 1 December 2022
  • 3rd Corrigendum: REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  of 15 March 2023
  • 4th Corrigendum: REGULATION (EU) 2024/1860 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  of 13 June 2024
• Other
  • MDR checklist as part of the free Starter Kit
  • Comparison of MDR and IVDR (PDF) in English
  • Comparison of MDR and IVDR (PDF) in German

4. Background information

4.1 How the EU regulations came about

It is often claimed that the breast implant scandal triggered the revision of medical device legislation. However, most stakeholders now deny this. Therefore, it is largely unclear who initiated the new regulation and for what reason.

4.2 Difference between EU regulations and EU directives

Like all EU directives, the “old” EU medical device directives had to be transposed into national laws and national regulations in order to become law. In Germany, these were the “Medizinproduktegesetz” (MPG) and ordinances such as the Medical Devices Operator Regulation (still valid) and the Medical Devices Safety Plan Regulation (now invalid).

The EU regulations (here: MDR, IVDR) have a direct legal character. National laws only supplement these regulations, such as the MPDG and others in Germany, with penal provisions and the definition of responsibilities of the national competent authorities.

4.3 Criticism of the Medical Device Regulation

The criticism of the EU medical device regulations is massive. Efforts and costs have multiplied for manufacturers. The time taken for the “approval procedures” has also increased.

As a result, competitiveness, innovation, and the supply of medical devices have been hampered.

These consequences were already feared in 2020.

For future regulation, it is essential to understand the system – a task for regulatory science.

5. Conclusion and summary

The Medical Device Regulation MDR is a comprehensive piece of legislation that poses significant challenges for all stakeholders (medical device manufacturers, notified bodies, distributors, importers, hospitals). It is not apparent that the MDR will improve medical devices’ safety, performance, and effectiveness. However, the supply of medical devices is at risk.

Manufacturers have little choice but to deal intensively with this legislation and comply with its requirements. These increased requirements are not limited to the “approval” (pre-market phase) but also explicitly affect the post-market phase (post-market surveillance, vigilance).

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Support with the implementation of the MDR

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Change history (as of May 2021)

• 2024-08-27: Links to corrigenda corrected and links grouped hierarchically in chapter 3.2
• 2024-01-18: Chapter numbering changed
• 2023-04-18: Article completely rewritten
• 2021-10-10: Section 7.e) (The consequences were not considered and are not understood) added
• 2021-07-26: Link to new corrigendum added
• 2021-05-24: New article on the declaration of conformity linked