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)
Commission Implementing Regulation (EU) 2022/1107of 4 July 2022laying 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/EUOJ L 117, 5.5.2017, p. 176., 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 CouncilDirective 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).. The common technical specifications set out in Commission Decision 2002/364/ECCommission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (OJ L 131, 16.5.2002, p. 17). 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: