WHAT IS THE AIM OF THE REGULATION?
- It updates the rules on placing, making available and putting into service medical devices1 for human use and their accessories on the European Union (EU) market.
- It also contains rules on how clinical investigations2 concerning such devices and accessories are carried out in the EU.
- It aims to improve patient safety by introducing more stringent procedures for conformity assessment (to ensure that unsafe or non-compliant devices do not end up on the market) and post-market surveillance.
- Amending Regulation (EU) 2020/561 was adopted to allow EU Member States and their authorities and institutions to prioritise the fight against the COVID-19 pandemic. It defers the application of certain rules of Regulation (EU) 2017/745 by 1 year, in order to ensure the smooth functioning of the EU’s internal market, to maintain a high level of protection of public health and patient safety, to provide legal certainty and to avoid potential market disruption during the pandemic.
KEY POINTS
Scope
Besides medical devices, the regulation also covers certain groups of products which 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, of which some 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 for 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.
- In the event of damages due to a defective device, a manufacturer’s authorised representative is jointly and severally liable.
- Where hazardous substances which are carcinogenic, mutagenic or toxic to reproduction or which 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
These devices may only be reprocessed (cleaned, disinfected, tested, restored for technical and functional safety and sterilised) 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.
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.
Eudamed
A centralised system, the European database on medical devices (Eudamed), will be developed to provide Member States, economic operators, patients, healthcare professionals and the public with information on medical devices available in the EU.
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;
- adverse effects on the device caused by instruments present at the time of investigations or treatment;
- 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 here.
Repeal of existing legislation – Directives 90/385/EEC and 93/42/EEC
The regulation, as amended by Regulation (EU) 2020/561, repeals Directives 90/385/EEC and 93/42/EEC from 26 May 2021, laying down specific transitional rules and some exceptions in Articles 120 and 122.
FROM WHEN DOES THE REGULATION APPLY?
It entered into force on 25 May 2017 and, further to amending Regulation (EU) 2020/561, has applied from 26 May 2021, 1 year later than originally intended. However, the dates of application for some of the regulation’s rules vary and are detailed in Articles 120, 122 and 123, as amended.
BACKGROUND
- This regulation is one of two adopted by the EU to overhaul its laws on medical devices. The second regulation (Regulation (EU) 2017/746, see summary) concerns in vitro diagnostic medical devices.
- For further information, see:
KEY TERMS
- Medical device. A term covering a wide variety of products used, for instance, for: It does not achieve its principal intended action by pharmacological, immunological or metabolic means, but the latter may assist in its function. Examples range from bandages through hip replacements to pacemakers. The complete definition of the term medical device is laid down in Article 2(1) of Regulation (EU) 2017/745.
- Clinical investigation. A systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.
- Invasive medical devices. A device which, wholly or partially, penetrates the body, either through an orifice or through the surface of the body.
MAIN DOCUMENT
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, pp. 1–175).
Successive amendments to Regulation (EU) 2017/745 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, pp. 176–332).
See consolidated version.
