As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensuring, among other things, that data generated in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigation is protected.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the market of
medical devices after they have already been put into service such as in the context of second-hand sales.
(4) Key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity
assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be
significantly reinforced, whilst provisions ensuring transparency and traceability regarding medical devices should
be introduced, to improve health and safety.
(5) To the extent possible, guidance developed for medical devices at international level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulators Forum (IMDRF), should be taken into account to promote the global convergence of regulations
which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identification, general safety and performance requirements, technical documen
tation, classification rules, conformity assessment procedures and clinical investigations.
(6) For historical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulated in two separate legal instruments. In the interest of
simplification, both directives, which have been amended several times, should be replaced by a single legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimited from other Union harmonisation
legislation concerning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Therefore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (
1
) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regard across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State, having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, category or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropriate level of consultation of the European Medicines
Agency (EMA), the European Chemicals Agency and the European Food Safety Authority, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (
2
).
(10) Products which combine a medicinal product or substance and a medical device are regulated either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (
3
) The two legislative
acts should ensure appropriate interaction in terms of consultations during pre-market assessment, and of
exchange of information in the context of vigilance activities involving such combination products. For medicinal
products that integrate a medical device part, compliance with the general safety and performance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the marketing
authorisation for such medicinal products. Directive 2001/83/EC should therefore be amended.
5.5.2017 L 117/2 Official Journal of the European Union
EN
1
) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(
2
) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(
3
) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).