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Ensuring the safety and performance of medical devices

Ensuring the safety and performance of medical devices

 

SUMMARY OF:

Regulation (EU) 2017/745 on medical devices

WHAT IS THE AIM OF THE REGULATION?

  • It updates the rules on placing on the EU market, making available and putting into service medical devices* for human use and their accessories.
  • It also contains rules on how evaluations on products are carried out in the EU concerning such devices (or accessories).
  • It aims to improve patient safety by introducing more stringent procedures for conformity assessment (to ensure that unsafe or non-compliant equipment does not end up on the market) and post-market surveillance.

KEY POINTS

Scope

Besides the variety of 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 equipment for liposuction. For more details about the list of those groups of products, see the regulation’s Annex XVI.

Classification

Medical devices are classified according to their intended purpose and their inherent risks (classes I, IIa, IIb and III — for more details, see the regulation’s Annex VIII).

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 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.

Clinical data

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

Manufacturers’ obligations

  • Manufacturers have clearer and more stringent obligations to monitor the quality, performance and safety of devices.
  • They are required to have measures in place that correspond to the level of risk, type of device and size of company. They must ensure they have sufficient financial coverage with respect to their potential liability under the product liability directive as well as put in place effective quality management and post-market surveillance systems.
  • 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 contained in invasive medical devices beyond a certain threshold, manufacturers must provide a justification to the notified body regarding their presence.

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 identification (UDI) system. This will ensure that, should problems arise, measures can be taken more rapidly.

Single-use devices

These devices may only be reprocessed (disinfected, cleaned, remanufactured, tested, packaged, labelled and sterilised) if permitted under national law and meet certain conditions laid down in this regulation. The manufacturer is responsible for the reprocessing of the device and assumes the obligations of a manufacturer. In certain cases, EU countries may allow for exceptions to the general rules where the reprocessing is undertaken by healthcare centres, provided that certain specific requirements laid down in the regulations 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 EU countries to encourage and enable healthcare professionals, users and patients to report suspected incidents at national level using harmonised formats.

Market surveillance

Competent EU authorities are responsible for ensuring that any unsafe device is withdrawn from the market.

Eudamed

A centralised database, called the European Databank on Medical Devices (Eudamed) will be developed to provide EU countries, businesses, 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 UDI and the manufacturer’s details,
  • measures or precautions to be taken concerning reciprocal interference with ‘reasonably foreseeable external influences’, medical examinations or environmental conditions,
  • the expected lifetime of the device and any necessary follow-up.

Repeal of existing legislation — Directives 90/385/EEC and 93/42/EEC

The regulation repeals Directives 90/385/EEC and 93/42/EEC from 25 May 2020 with some exceptions laid down in Article 122.

FROM WHEN DOES THE REGULATION APPLY?

It entered into force on 25 May 2017 and applies from 26 May 2020. However, dates of application for some of the regulation’s articles vary and are detailed in Articles 120 and 123.

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) concerns in vitro diagnostic medical devices.

For more information, see:

KEY TERMS

Medical device: term covering a wide variety of equipment used for:
  • diagnosing, preventing, monitoring, treating or alleviating diseases or injuries;
  • controlling conception;
  • investigating, replacing, modifying or supporting the anatomy;
  • supporting or sustaining life, etc.

It does not achieve its primary 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.

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)

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)

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, pp. 1-43)

Successive amendments to Directive 93/42/EEC have been incorporated into the original text. This consolidated version is of documentary value only.

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.6.1990, pp. 17-36)

See consolidated version.

last update 26.10.2017

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