Implementing regulation 2022/1107 - Common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation 2017/746 - Main contents
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official title
Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council| Legal instrument | Implementing regulation |
|---|---|
| Number legal act | Implementing regulation 2022/1107 |
| Regdoc number | C(2022)4498 |
| CELEX number i | 32022R1107 |
| Document | 04-07-2022; Date of adoption |
|---|---|
| Publication in Official Journal | 05-07-2022; OJ L 178 p. 3-56 |
| Effect | 25-07-2022; Entry into force Date pub. +20 See Art 4 25-07-2022; Application Partial application See Art 4 25-07-2024; Application See Art 4 |
| End of validity | 31-12-9999 |
5.7.2022 |
EN |
Official Journal of the European Union |
L 178/3 |
COMMISSION IMPLEMENTING REGULATION (EU) 2022/1107
of 4 July 2022
laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to 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 (1), and in particular Article 9(1) thereof,
Whereas:
(1) |
For certain class D in vitro diagnostic medical devices falling within the scope of Regulation (EU) 2017/746, harmonised standards do not exist as regards certain requirements of Annex I to that Regulation, and there is a need to address public health concerns as the risk associated with the use of those devices is significant for public health and patient safety. It is therefore appropriate to adopt common specifications for those devices in respect of those requirements. |
(2) |
Regulation (EU) 2017/746 replaces Directive 98/79/EC of the European Parliament and of the Council (2). The common technical specifications set out in Commission Decision 2002/364/EC (3) for certain devices covered by Directive 98/79/EC remain relevant. Those common technical specifications have therefore been taken into account and where necessary updated to reflect the state of the art. |
(3) |
To allow manufacturers, other economic operators, notified bodies and other actors to adapt to this Regulation, and to ensure its proper application, it is appropriate to defer its application. However, in the interest of public health and patient safety, manufacturers should be allowed to comply with the common specifications laid down in this Regulation on a voluntary basis before its date of application. |
(4) |
To ensure a continuous high level of safety and performance of devices, as a transitional measure it should be provided that devices that are in conformity with Decision 2002/364/EC are to be presumed to be in conformity with the requirements for certain performance characteristics set out in Annex I to Regulation (EU) 2017/746 until the date of application of this Regulation. |
(5) |
The Medical Device Coordination Group has been consulted. |
(6) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices, |
HAS ADOPTED THIS REGULATION:
Article 1
Common specifications
This Regulation lays down common specifications for certain class D in vitro diagnostic medical devices in respect of the requirements regarding the performance characteristics set out in Section 9.1, points (a) and (b), Section 9.3 and Section 9.4, point (a), of Annex I to Regulation (EU) 2017/746.
Annex I lays down common specifications for devices covered by Annexes II to XIII, as specified in that Annex.
Annex II lays down common specifications for devices intended for detection of blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems.
Annex III lays down common specifications for devices intended for detection or quantification of markers of human immunodeficiency virus (HIV) infection.
Annex IV lays down common specifications for devices intended for detection or quantification of markers of human T-cell lymphotropic virus (HTLV) infection.
Annex V lays down common specifications for devices intended for detection or quantification of markers of hepatitis C virus (HCV) infection.
Annex VI lays down common specifications for devices intended for detection or quantification of markers of hepatitis B virus (HBV)...
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