In vitro diagnostic medical devices are devices, reagents or software used to examine specimens from the body, for example blood or tissue samples. They are used to diagnose diseases, assess health risks or monitor treatment.

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) is implemented by the Act on Medical Devices, No. 132/2020.

In vitro diagnostic medical devices are divided into risk classes A, B, C and D, where D is the highest risk class. Correct classification of devices is the responsibility of the manufacturer. A notified body carries out the conformity assessment procedure and CE certification of the devices. Devices in risk class A are, however, exempt from the requirement for the involvement of a notified body unless they are sterile.

As with other medical devices, in vitro diagnostic medical devices are required to be registered in EUDAMED and to carry a unique device identifier (UDI).

Timelines under the previous regulation and the one currently in force

The timelines for the conformity assessment of in vitro diagnostic medical devices are as follows:

• Certificates issued by a notified body before 25 May 2017 in accordance with the In Vitro Diagnostic Medical Device Directive 98/79/EC (IVDD) expired in 2025.

• Certificates issued by a notified body after 25 May 2017 in accordance with the IVDD, which were still valid on 26 May 2022 and have not been withdrawn since then, expire in accordance with the expiry date of the certificate, or no later than 31 December 2027.

• Certificates issued by a notified body after 25 May 2017 in accordance with the IVDD, which were still valid on 26 May 2022 but expired before 9 July 2024, shall be considered valid until 31 December 2027, provided that one of the following conditions is met:

  • A confirmation letter has been issued for the device in question.

  • The device has been granted a derogation under Article 54 of the IVDR, or a requirement under Article 92 of the IVDR is in force.

• Devices with certification for which the involvement of a notified body was not required under the IVDD, but for which the involvement of a notified body is now required under the IVDR, and for which a declaration of conformity was issued before 26 May 2022, may be made available on the market or put into service, subject to certain conditions (see points 3c, d and e of Article 110 of the IVDR), within the following time limits:

  • Risk class D: 31 December 2027

  • Risk class C: 31 December 2028

  • Risk class B: 31 December 2029

  • Risk class A sterile devices: 31 December 2029

• Devices not covered by the transitional provisions of the IVDR:

  • In vitro diagnostic medical devices that have a certificate in accordance with the IVDD from a notified body but do not require a certificate from a notified body under the IVDR.

  • All in vitro diagnostic medical devices certified and placed on the market after 26 May 2022. New in vitro diagnostic medical devices, and devices whose design or intended purpose has changed, must comply with the requirements of the IVDR.

  • If the manufacturer of a CE-marked medical device loses the CE marking, it is possible to apply for a derogation for its use under Article 54 of the IVDR.

It is important to report incidents to IMA

The Icelandic Medicines Agency (IMA) reiterates that anyone who manufactures, sells, distributes, owns or uses medical devices and is aware of an incident, deviation, defect or malfunction that could cause or has caused harm to the health of a user, or their death, is obliged to report it to IMA.

In-house manufacture for healthcare institutions

Special rules apply to in vitro diagnostic medical devices that are manufactured by, and used only within, a particular healthcare institution (in-house in vitro diagnostic medical devices).

Such manufacture is permitted subject to certain conditions set out in Article 5(5) of the IVDR.

Healthcare institutions must justify in their documentation that the specific needs of the target patient group cannot be met, or cannot be met adequately, by an equivalent device available on the market.

IMA may require healthcare institutions to submit all documentation relating to such manufacture. IMA is also authorised to examine and restrict such manufacture and the use of the devices concerned. In vitro diagnostic medical devices manufactured by a healthcare institution for use within the institution itself do not require certification by a notified body.