Scope of application

Article 1

Purpose and Scope

1. This Regulation lays down rules for the placing on the market, making available on the market and putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations relating to medical devices and accessories carried out in the Union.

2. This Regulation shall also apply, from the date of application of the common specifications adopted pursuant to Article 9, to the groups of devices not for medical purposes listed in Annex XVI, taking into account the latest medical knowledge and, in particular, existing harmonized standards for analogous devices for medical purposes, based on similar technology. The common specifications relating to each of the groups of devices listed in Annex XVI shall, at least, concern the application of the risk management set out in Annex I.
for the group of products concerned and, where necessary, to the clinical evaluation relating to safety. The necessary common specifications shall be adopted at the latest
►M1 26 May 2021 ◄. They shall apply on the later of the following two dates: from six months after their entry into force, or from ►M1 26 May 2021 ◄.
By way of derogation from Article 122, Member States' measures concerning the qualification of the devices referred to in Annex XVI as medical devices within the meaning of Directive 93/42/EEC shall remain valid until the date of application referred to in the first subparagraph of the relevant common specifications for this group of devices.
This Regulation also applies to clinical investigations carried out in the Union relating to the devices referred to in the first subparagraph.

3. Products that have both medical and non-medical purposes must cumulatively comply with the requirements applicable to products with medical purposes and those applicable to products without medical purposes.

4. For the purposes of this Regulation, medical devices, accessories for medical devices and devices listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall be referred to as "products".

5. Where justified by the similarity between a device placed on the market for an intended medical purpose and a device not intended for a medical purpose in terms of their characteristics and risks, the Commission shall be empowered to adopt delegated acts in accordance with Article 115 to amend the list in Annex XVI by adding new groups of devices, in order to protect the health and safety of users or other persons, as well as other aspects of public health.

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7. Any device which, when placed on the market or put into service, incorporates as an integral part an in vitro diagnostic medical device, as defined in Article 2(2) of Regulation (EU) 2017/746, shall be governed by this Regulation. The requirements of Regulation (EU) 2017/746 shall apply to
the part of the product that constitutes an in vitro diagnostic medical device.

8. Any device which, at the time of its placing on the market or putting into service, incorporates as an integral part a substance which, used separately, would be considered a medicinal product as defined in point 1 of Article 2 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 1 of Article 10 of that Directive, and which has an action ancillary to that of the product, shall be assessed and authorised in accordance with this Regulation.
However, if the action of that substance is primary and not accessory
Regarding the product, the integrated product will be regulated by the
Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), as appropriate. In that case, the relevant general safety and performance requirements of Annex I to this Regulation shall apply to the safety and performance of the part constituting a medical device.

9. Any product that is intended to administer a medicine,
as defined in Article 1(2) of Directive 2001/83/EC, shall be regulated by this Regulation, without prejudice to the provisions of that Directive and Regulation (EC) No 726/2004 as regards the medicinal product.
However, if the product intended to administer a medicine and the
medicinal product is placed on the market in such a way that it constitutes a single integrated product intended to be used exclusively as such and which is not reusable, said single integrated product shall be regulated by Directive 2001/83/EC or Regulation (EC)
No. 726/2004, as appropriate. In that case, the relevant general safety and performance requirements of Annex I to this Regulation shall apply with regard to safety and performance.
of the part that constitutes a medical device of the single integrated product.

10. Any product that, when introduced into the market or put into service, incorporates as an integral part tissues or cells of non-viable human origin or their derivatives, which have an accessory action with respect to that of the product, must be evaluated and authorized with
in accordance with this Regulation. In this case, the provisions on donation, procurement, and evaluation laid down in Directive 2004/23/EC shall apply.
However, if the action of such tissues or cells or their derivatives is primary and not accessory to that of the product and the product is not regulated by Regulation (EC) No 1394/2007, the product shall be regulated by Directive 2004/23/EC. In such a case, the following shall apply:
the relevant general safety and operating requirements of the
Annex I to this Regulation as regards the safety and functioning of the part constituting a medical device.

11. This Regulation constitutes specific Union legislation for the purposes of Article 2(3) of Directive 2014/30/EU.
▼C3
(1) Regulation (EC) No 726/2004 of the European Parliament and of the Council,
of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human use and
veterinarian and establishing the European Medicines Agency
(OJ L 136 of 30.4.2004, p. 1)

12. Products which are also machinery within the meaning of point (a) of Article 2, second paragraph, of Directive 2006/42/EC of the European Parliament and of the Council (1) shall also comply with:
where a hazard exists for the purposes of that Directive, the essential health and safety requirements set out in Annex I to that Directive, to the extent that those requirements are more specific
the safety and operational requirements set out in Chapter II of Annex I to this Regulation.

13. This Regulation shall apply without prejudice to Directive 2013/59/Euratom.

14. This Regulation shall apply without prejudice to the right of
Member States to restrict the use of any specific type
of the product in relation to aspects not regulated by this
Regulation.

15. This Regulation shall apply without prejudice to national law relating to the organisation, provision or financing of health services and medical care, such as the requirement that certain products may be supplied only on medical prescription, the requirement that only certain health professionals or health establishments may dispense or use certain products or that
its use must be accompanied by specific professional advice.

16. Nothing in this Regulation shall restrict the freedom
of the press or freedom of expression in the media insofar as such freedoms are guaranteed in the Union and in the Member States, in particular by virtue of Article 11 of the Charter of Fundamental Rights of the European Union.