Ensuring the safety and performance of medical devices

KEY POINTS

Scope

Besides medical devices, the regulation also covers certain groups of products that do not have an intended medical purpose. These include coloured contact lenses (i.e. lenses that do not correct vision) and liposuction equipment. A list of these products is included in Annex XVI to the regulation.

Classification

Medical devices are classified according to their intended purpose and their inherent risks (classes I, IIa, IIb and III as set out in Annex VIII to the regulation).

Notified bodies

• The regulation tightens the rules concerning how the independent notified bodies – which assess the conformity of medium- and high-risk medical devices before they are placed on the market – are designated, organised and monitored.
• These bodies have to meet the same high-quality standards throughout the EU and must have the required competences, resources and staff to successfully perform their conformity assessment tasks.
• On-site inspections of manufacturers, some of which are unannounced, must be carried out.
• Assessments of certain high-risk devices (e.g. implants) might also involve EU-level panels of independent experts (expert panels).

Clinical data

• The regulation specifies what is required in the data collection of clinical investigations on medical devices. These requirements have been, to a large extent, aligned with those applicable to clinical trials on medicinal products. They include rules on informed consent and protecting vulnerable subjects (e.g. people under the age of 18, pregnant women or incapacitated people).
• Clinical investigations conducted in more than one Member State will be subject to a single coordinated assessment.

Obligations of manufacturers and other economic operators

• Manufacturers have clearer and more stringent obligations to monitor the quality, performance and safety of devices.
• They must ensure sufficient financial coverage with respect to their potential liability under Directive 85/374/EEC on product liability (see summary) and the related measures must be proportionate to the risk class, the type of device and the size of the enterprise.
• Manufacturers have to establish quality management and post-market surveillance systems proportionate to the risk class and the type of device.
• Under the current rules, in the event of damages due to a defective device, a manufacturer’s authorised representative is jointly and severally liable.
• Where hazardous substances that are carcinogenic, mutagenic or toxic to reproduction or that can interfere with endocrine systems are present in invasive medical devices³ beyond a certain threshold, manufacturers must justify their presence to the notified body.
• Specific obligations are also established for related economic operators: authorised representatives, importers, distributors and those dealing with systems and procedure packs.

Traceability

The regulation introduces a system for registering devices and manufacturers, importers and authorised representatives to ensure the traceability of devices throughout the supply chain by means of a unique device identifier. This will ensure that measures can be taken rapidly if problems arise.

Single-use devices

The regulation currently allows these devices to be reprocessed (cleaned, disinfected, tested, restored for technical and functional safety and sterilised) only if permitted under national law and if they meet certain conditions laid down in this regulation. Any individual or legal person who reprocesses a single-use device to make it suitable for further use assumes the obligations of a manufacturer. In certain cases, Member States may allow for exceptions to the general rules where the single-use device is reprocessed and used within a health institution, provided that certain specific requirements laid down in the regulation are fulfilled.

A European Commission legislative proposal of 16 December 2025 would require manufacturers to explain why a device is labelled as single-use and would introduce new rules on when such devices may be reprocessed.

Incident reporting

In addition to the obligation for manufacturers to report serious incidents and trends in non-serious incidents, the regulation introduces obligations for Member States to encourage and enable healthcare professionals, users and patients to report suspected incidents at the national level using standardised formats.

Market surveillance

The relevant EU authorities are responsible for ensuring that any unsafe or non-compliant device is not placed on the market, or is withdrawn from the market if found to be unsafe after being placed on the market.

European database on medical devices

A centralised system, Eudamed, is being developed and progressively implemented to provide Member States, economic operators, patients, healthcare professionals and the public with information on medical devices available in the EU. The rules on the gradual deployment and use of Eudamed were amended by Regulation (EU) 2024/1860. Several electronic systems within Eudamed were declared functional by Decision (EU) 2025/2371, triggering the transition periods for their mandatory use, with the first modules becoming mandatory from 28 May 2026.

Implant card

In the case of implantable devices, manufacturers must provide patients with key information on an implant card delivered with the device. This includes:

• the identification of the device, its name, serial number, lot number, the unique device identifier and the manufacturer’s details;
• warnings, precautions or measures to be taken regarding possible interference from external influences, medical examinations or environmental conditions;
• the expected lifetime of the device and any necessary follow-up.

Implementing acts

The full list of implementing acts to Regulation (EU) 2017/745 can be found on this page.

Repeal

Regulation (EU) 2017/745, as amended by Regulation (EU) 2020/561, repealed and replaced Directives 90/385/EEC and 93/42/EEC as of 26 May 2021. It lays down specific transitional rules and some exceptions in Articles 120 and 122, which were subsequently amended by Regulation (EU) 2023/607 to extend the transitional periods for certain devices previously certified under those directives.