Author:: Publications Office of the European Union
Responsible entity(ies):: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs

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Ensuring the safety and performance of in vitro diagnostic medical devices

SUMMARY OF:

Regulation (EU) 2017/746 on in vitro diagnostic 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 in vitro diagnostic (IVD) medical devices * for human use and their accessories.
It also contains rules on the conduct of performance studies * that are carried out in the EU concerning IVD medical devices (or accessories).
It aims to improve patient safety by introducing stricter procedures for conformity assessment (to ensure that unsafe or non-compliant devices do not end up on the market) and post-market surveillance.

KEY POINTS

Scope

It covers IVD medical devices for human use and their accessories. However, devices manufactured and used in the same healthcare centre are exempted from the rules laid down by this regulation, other than the relevant general safety and performance requirements, so long as a number of conditions are fulfilled.

Classification system

The classification system for IVD medical devices has been adapted to the rapid scientific progress in the field and to the international guidance. They are classified according to their intended purpose and their inherent risks (classes A, B, C and D — 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.

Clinical data

The regulation specifies what is required in the data collection of performance studies on IVD medical devices. These have been 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).
Performance studies conducted in more than one EU country will be subject to a 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 quality management and post-market surveillance systems.
In the event of damages due to defective devices, a manufacturer’s authorised representative is jointly and severally liable.

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 system. This will ensure that, should problems arise, measures can be taken rapidly.

High-risk devices

In the event of the first certification for class D IVD devices, and when common specifications are not available, designated reference laboratories will check the performance claimed by their manufacturers and an expert panel will be consulted on innovative devices of the same class. Although the notified body is not bound by the panel’s opinion, it has to provide a justification for not following it. Nevertheless, the notified body shall not deliver this first certificate if the scientific opinion of the EU reference laboratory is negative.

Genetic counselling

Patients tested with a genetic test must be provided with all relevant information on its nature, significance and implications. They must be given appropriate access to counselling in cases where a test provides information on the genetic predisposition for medical conditions and/or diseases which are generally considered to be untreatable.

Incident reporting

In addition to the obligation for manufacturers to report serious incidents (resulting in death or a serious deterioration in a person’s health) and trends in non-serious incidents (for example, side-effects from the use of a device), the regulation introduces the obligation for EU countries to encourage and enable healthcare professionals, users and patients to report suspected incidents at national level.

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.

Repeal of existing legislation — Directive 98/79/EC and Commission Decision 2010/227/EU

The regulation repeals Directive 98/79/EC and Decision 2010/227/EU from 26 May 2022, with some exceptions laid down in Article 112.

FROM WHEN DOES THE REGULATION APPLY?

It entered into force on 25 May 2017 and applies from 26 May 2022. Dates of application for some of the regulation’s articles vary and are detailed in Articles 110 and 113.

BACKGROUND

This regulation is one of 2 adopted by the EU to overhaul its laws on medical devices. The second regulation (Regulation (EU) 2017/745) concerns medical devices.

For more information, see:

Medical devices (European Commission).

Following the COVID-19 outbreak and introducing measures to cope with the impact of the crisis, the European Commission adopted:

Communication from the Commission — Guidelines on COVID-19 in vitro diagnostic tests and their performance

KEY TERMS

In vitro diagnostic medical devices: term covering a wide variety of devices used for providing information on:

(a) a physiological or pathological process or state;

(b) a congenital physical or mental impairment;

(d) the safety and compatibility between the materials used and the specimens of the body intended to be used;

(e) treatment response or reactions;

(f) defining or monitoring therapeutic measures.

Examples range from self-tests for pregnancy through to tests for highly transmissible substances using specimens taken from the human body.

Performance studies: studies that demonstrate that an IVD medical device complies with the necessary regulatory requirements through conformity assessment procedures.

MAIN DOCUMENT

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)

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