Everything you need to know

by 184yw8rhwhr
August 28, 2024

The European one Medical Devices Regulation MDR (EU Regulation on Medical Devices) must be taken into consideration by manufacturers intending to market medical devices in the EU.

This Regulation (EU) 2017/745 on medical devicesthe official title, also imposes requirements on notified bodies, traders, importers and healthcare facilities such as hospitals.

… for beginners

If you are brand new, download this free starter kit below. It offers you an overview of the legislation, shows you the steps for “approval” of your medical device and contains the MDR checklist in PDF and DOCX format for download.

… for advanced users

Learn more about the details with this page and the specialist articles linked to it.

Use that Consolidated version of the MDR in German or English. This summarizes all changes to the MDR, including the transition periods extended to March 2023. Internal links make it easy to navigate the regulation, which is over 170 pages long.

… for IVDR manufacturers

Manufacturers of in vitro diagnostic instruments should read the specialist article on IVDR.

… for importers, retailers and operators

Watch the following video and then read the specialist articles linked in chapter 1.b).

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1. Overview of MDR requirements

1.1 Requirements for manufacturers and their medical devices

The requirements imposed on manufacturers by the Medical Devices Regulation are numerous.

1.1.1 Requirements transversal to the product

MDR requirement and links to specialist articles	Explanation
Quality management system	All manufacturers need a QM system, among other things, for the development, production and monitoring of products on the market. With the exception of Class I products, certification is usually required.
Risk management system	Risk management must ensure throughout the product life cycle that the benefits are acceptable given the risks.
Verantwortliche Person (“Person responsible for regulatory compliance”)	Manufacturers are required to employ a person responsible for regulatory compliance and e.g. B. ensures that technical documentation is created in accordance with the company’s own QM system.

Table 1: The requirements for producers, their systems and roles

1.1.2 Product-specific requirements

MDR requirement and links to specialist articles	Explanation
Product classification	The manufacturer must determine the risk class for each product.
Fundamental safety and performance requirements and technical documentation	The technical documentation must meet the requirements of Annex II and provide all evidence of compliance with the essential requirements of Annex I. For this proof, manufacturers are required to use harmonized standards and common specifications.
Clinical evaluation	As part of the clinical evaluation, the manufacturer must continuously verify whether the safety, performance and benefits of the products are met. If clinical data are not sufficient, a clinical trial is necessary.
Unique Device Identification (UDI)	All medical devices must receive a unique identification, the UDI. The products must therefore be registered in EUDAMED.
Labeling	The MDR precisely specifies requirements for instructions for use, other accompanying materials and other labeling such as printouts and packaging.
Conformity assessment	Depending on the risk class of the product, the manufacturer may undergo a conformity assessment procedure. To this end it must involve a notified body, with the exception of class I products. If successful, it will have to complete a declaration of conformity and affix the CE marking.
Post-market surveillance and surveillance	Manufacturers are obliged to monitor their medical devices placed on the market throughout their useful life, to continuously collect data and, if necessary, react to them. If there are risks it is necessary to inform the authorities.

Table 2: Specific MDR requirements for products

1.2 Requirements for other actors (retailers, importers, etc.)

Not only medical device manufacturers have to comply with the Medical Device Regulation, but also other actors:

2. Structure and structure of the MDR

The Medical Devices Regulation is made up of 123 articles, divided into 10 chapters. It also has 17 appendages.

2.1 The chapters

The Medical Devices Regulation (MDR) is completely restructured compared to the old Medical Devices Directive (MDD):

Table 3: The chapters of the Medical Devices Regulation

Mindmap shows the chapter overview of the MDR Medical Device Regulation — Fig. 1: The complete mind map is available for download in Auditgarant and as part of the free Starter Kit.
It provides a quick overview of the MDR, which contains more than 170 pages.

2.2 The appendices

The MDR has 17 appendices.

Table 4: The annexes to the Medical Devices Regulation

3. Further articles and specialist links

3.1 Other specialist articles

The EU has postponed the transition periods for moving to the MDR several times. The rules are so complex that a specialist article on transition periods will help.

The Medical Device Coordination Group (MDCG) has published further explanations and requirements.

There are different requirements for products without a medical purpose (‘Annex XVI products’).

3.2 Further connections

MDR (original text)
To be corrected
Various

4. Basic information

4.1 How community regulations were born

It is often said that the breast implant scandal was the trigger for the revision of the Medical Devices Act. But most actors now deny it. It is therefore largely unclear who initiated the new regulation and for what reason.

4.2 Difference between community regulations and community directives

The “old” EU medical devicesGuidelines Like all EU directives, they had to be translated into national laws and regulations to gain legal force. In Germany these were the Medical Device Act (MPG) and regulations such as the Medical Device Operators Ordinance (still valid) and the Medical Device Safety Plan Ordinance (now invalid).

Dying EU-Regulations (here: MDR, IVDR) have a direct legal character. National laws simply supplement these rules, such as the MPDG in Germany, with criminal provisions and the determination of the competent authorities.

4.3 Criticisms of the Medical Devices Regulation

Criticism of EU legislation on medical devices is enormous. The efforts and costs for producers have multiplied. The duration of the “approval process” also applies.

As a result, competitiveness, innovation and supply of medical devices are hampered.

These consequences were already feared in 2020.

For future regulation it is important to understand the system: a task of regulatory science.

5. Conclusion and summary

The MDR Medical Devices Regulation is a very broad piece of legislation that poses great challenges to all actors (medical device manufacturers, notified bodies, importers, retailers, hospitals). There is no evidence that MDR improves the safety, performance and effectiveness of medical devices. However, it is clear that the supply of medical devices is suffering.

Manufacturers have no choice but to intensively engage with this body of law and meet its requirements. These increased requirements are not limited to the “approval” (pre-market phase), but also explicitly influence the post-market phase (post-market surveillance, vigilance).

Help with MDR implementation

Free offers

Still have questions about MDR and its implementation? You can get answers in our free micro-consultation.

Download this free starter kit which offers an overview of the regulatory landscape and contains the MDR checklist in PDF and DOCX format.

Video and e-learning

Video training courses in Auditgarant show you step by step how to create your technical documentation and QM system in a lean, fast and MDR compliant way. Over 100 templates and sample documents are available for download. This way you will create the conditions for your products to be approved and placed on the market quickly and safely.

Product testing

Johner Institute experts will help you test your products:

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Change history (as of May 2021)

08-27-2024: In chapter 3.2 the links to the corrections have been corrected and the links have been grouped hierarchically
2024-01-18: Chapter numbering has been changed
2023-04-18: Article completely rewritten
2021-10-10: Added paragraph 7.e) (Consequences have not been considered and are not understood)
2021-07-26: Added link to new corrigendum
2021-05-24: New DoC post linked