Article 1: Subject matter and scope

1. This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of in vitro diagnostic medical devices for human use and accessories for such devices in the Union. This Regulation also applies to performance studies concerning such in vitro diagnostic medical devices and accessories conducted in the Union.

2. For the purposes of this Regulation, in vitro diagnostic medical devices and accessories for in vitro diagnostic medical devices shall hereinafter be referred to as ‘devices’.

3. This Regulation does not apply to:

(a) products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;

(b) invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen;

(c) internationally certified reference materials;

(d) materials used for external quality assessment schemes.

4. Any device which, when placed on the market or put into service, incorporates, as an integral part, a medical device as defined in point 1 of Article 2 of Regulation (EU) 2017/745 shall be governed by that Regulation. The requirements of this Regulation shall apply to the in vitro diagnostic medical device part.

5. This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU.

6. Devices which are also machinery within the meaning of point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council 22 shall, where a hazard relevant under that Directive exists, also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those requirements are more specific than the general safety and performance requirements set out in Chapter II of Annex I to this Regulation.

7. This Regulation shall not affect the application of Directive 2013/59/Euratom.

8. This Regulation shall not affect the right of a Member State to restrict the use of any specific type of device in relation to aspects not covered by this Regulation.

9. This Regulation shall not affect national law concerning the organisation, delivery or financing of health services and medical care, such as the requirement that certain devices may only be supplied on a medical prescription, the requirement that only certain health professionals or health care institutions may dispense or use certain devices or that their use be accompanied by specific professional counselling.

10. Nothing in this Regulation shall restrict the freedom of the press or the freedom of expression in the media in so far as those freedoms are guaranteed in the Union and in the Member States, in particular under Article 11 of the Charter of Fundamental Rights of the European Union.