The purpose of this Royal Decree is to regulate medical devices for human use and their accessories,
non-medical devices, and in particular:
a) The competent authority and health guarantees.
b) The procedures for granting prior licences for the operation of facilities.
c) The requirements and actions of notified bodies.
d) The reprocessing of single-use medical devices.
e) Marketing and commissioning in Spain.
f) Trade in the European Union market and in the foreign market.
g) Clinical research.
h) The monitoring system.
i) Inspection and control of the market and health protection measures.
This Royal Decree shall apply to:
a) Products falling within the scope of Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017. For the purposes of this Royal Decree, medical devices for human use and their accessories, and non-medical devices listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 are hereinafter referred to as ‘products’.
b) Devices and instruments used in permanent, semi-permanent make-up or tattooing of the skin using invasive techniques. Such devices shall not bear the CE marking and shall comply with the general safety andperformance requirements applicable to them. Their manufacture, import, distribution, and sale shall be subject to surveillance by the competent health authorities
Draft Royal Decree regulating medical devices.
The direct application of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 as of 26 May 2021 requires the adequacy of the current national legislation on medical devices, in order to repeal provisions relating to matters that will be directly regulated by the provisions of the Regulation, while implementing the regulatory measures required for those aspects where, in accordance with that Regulation, Member States are required to establish regulation at national level.
This standard is necessary for:
A) Establishing the requirements and procedures for the regulation of products manufactured and used in a
health facility (in house).
B) Establishing requirements and procedures for regulating the reprocessing of single-use medical devices.
C) Establishing the requirements and procedures for regulating the implanting card.
D) Establishing the creation of a national register for placing medical devices on the market.
D) Regulating the language regime.
F) Establishing the requirements for conducting clinical research in our country.
G) Establishing that, as regards Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, the competent authority is the Spanish Agency for Medicines and MedicalDevices, irrespective of the competence of other health authorities.