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 European Union (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* for 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

The regulation covers IVD medical devices for human use and their accessories (hereafter referred to as devices). However, devices manufactured and used in the same healthcare institution are exempted from the rules, other than those relating to the relevant general safety and performance requirements, so long as a number of conditions are fulfilled.

Classification system

The classification system for the 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 Annex VIII to the regulation).

Harmonised standards and common specifications

An implementing act adopted by the European Commission – Implementing Decision (EU) 2021/1195, as amended – lists the harmonised standards drafted in support of Regulation (EU) 2017/746.
Commission Implementing Regulation (EU) 2022/1107 lays down common specifications on the performance of certain class D devices. The manufacturers must follow the specifications or show that their alternative solution is at least equivalent in terms of the safety and performance of the device.

Notified bodies

The regulation tightens the rules concerning how the independent notified bodies, which assess the conformity of medium- and high-risk 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.
Implementing Regulation (EU) 2017/2185 sets out the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of IVDs.

Performance studies

The manufacturer must support its claims on the performance of the device with rigorous evidence, including scientific validity and analytical and clinical performance data.
The regulation specifies what is required in the data collection of high-risk performance studies on devices.
Performance studies conducted in more than one EU Member State will be subject to a coordinated assessment.
The regulation also applies to performance studies carried out in non-EU countries if they use specimens from EU patients.

Manufacturers’ obligations

Manufacturers:
- have clearer and more stringent obligations to monitor the quality, performance and safety of devices;
- are required to have measures in place that correspond to the level of risk, type of device and size of the company;
- must ensure they have sufficient financial coverage with respect to their potential liability under the product liability directive (see summary), along with 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

A system of unique device identifiers (UDIs) for registering devices and manufacturers, importers and authorised representatives ensures the traceability of devices throughout the supply chain and that, should problems arise, measures can be taken rapidly.
Implementing Decision (EU) 2019/939 lists the issuing entities designated to operate a system for the assignment of UDIs in the field of medical devices.

High-risk devices

In the event of the first certification for a new class D device, for which common specifications are not available, an expert panel will provide its views on the performance of the device. Although the notified body is not bound by the panel’s opinion, it has to provide a justification for not following it.
The Commission may designate EU reference laboratories that will test whether class D devices perform as claimed by the manufacturer. The notified body may not deliver the certificate for the device if the scientific opinion of the EU reference laboratory is negative.
The tasks of and criteria for the EU reference laboratories in the field of IVDs are set out in Implementing Regulation (EU) 2022/944.
Implementing Regulation (EU) 2022/945 sets out the rules on fees that may be levied by the EU reference laboratories in the field of IVDs.

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 that 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 (e.g. side effects from the use of a device), the regulation introduces the obligation for Member States to encourage and enable healthcare professionals, users and patients to report suspected incidents at the national level.

Market surveillance

The relevant authorities in the Member States are responsible for checking that devices on their market comply with the regulation and do not endanger health or safety of patients, users or other people.

Eudamed

A centralised database, called the European database on medical devices (Eudamed) is being developed to provide Member States, businesses, patients, healthcare professionals and the public with information on medical devices available in the EU.
Implementing Regulation (EU) 2021/2078 sets out the arrangements necessary for Eudamed’s set-up and maintenance.

Transition periods

Due to the challenges to ensuring proper implementation and application presented by the COVID-19 pandemic, Regulation (EU) 2017/746 was amended by Regulation (EU) 2022/112, which extended some transition periods for already marketed devices in accordance with their risk class, as follows:
- for higher risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), the transition period ends on 26 May 2025 and 26 May 2026 respectively;
- for lower risk devices such as class B devices and class A sterile devices, the transition period ends on 26 May 2027.
The transition period for most requirements applicable to devices manufactured and used within the same health institutions (in-house devices) was extended until May 2024. The requirement to justify that the needs of the patients cannot be met by an equivalent device on the market applies from May 2028.

Repeal of legislation

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 has applied since 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 two adopted by the EU to overhaul its laws on medical devices. The second regulation (Regulation (EU) 2017/745) concerns medical devices.
During the COVID-19 pandemic, given the need to test for the presence of or past exposure to the virus, the Commission adopted guidelines on COVID-19 in vitro diagnostic tests and their performance in April 2020.
For further information, see:
- Medical devices (European Commission)
- In vitro diagnostics – press release (European Commission)
- Progressive roll-out of the in vitro diagnostic medical devices regulation – press release (European Commission).

KEY TERMS

In vitro diagnostic medical devices. Term covering a wide variety of devices used to provide information on: (a) a physiological or pathological process or state; (b) a congenital physical or mental impairment; (c) the predisposition to a medical condition or disease; (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 to tests for highly transmissible agents using specimens taken from the human body.

Performance studies. Studies that establish or confirm the analytical or clinical performances of a device.

MAIN 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).

Successive amendments to Regulation (EU) 2017/746 have been incorporated in the original text. This consolidated version is of documentary value only.

Communication from the Commission – Guidelines on COVID-19 in vitro diagnostic tests and their performance (OJ C 122I, 15.4.2020, pp. 1–7).