Message 002
Communication from the Commission - TRIS/(2022) 02159
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2022/0431/E
No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.
(MSG: 202202159.EN)
1. MSG 002 IND 2022 0431 E EN 17-06-2022 E NOTIF
2. E
3A. Ministerio de Asuntos Exteriores, Unión Europea y Cooperación
Dirección General de Coordinación del Mercado Interior y Otras Políticas Comunitarias
Subdirección General de Asuntos Industriales, Energéticos, de Transportes y Comunicaciones y de Medio Ambiente
Calle Serrano Galvache 26, 4ª planta, Torre Sur, Madrid 28071
Tel. +34 91 379 8464, +34 91 379 8387, +34 91 379 8398
Fax +34 91 479 8401
Correo electrónico: d83_189@ue.mae.es
3B. AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS
DEPARTAMENTO DE PRODUCTOS SANITARIOS
C/CAMPEZO 1 28022 MADRID
TLF: 918225261
FAX:918225289
Correo electronico: cruizv@aemps.es
4. 2022/0431/E - S10S
5. Draft Royal Decree regulating medical devices.
6. PURPOSE
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.
SCOPE
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 and performance requirements applicable to them. Their manufacture, import, distribution, and sale shall be subject to surveillance by the competent health authorities
7. - NA
8. 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 Medical Devices, irrespective of the competence of other health authorities.
9. The standard has the following specific goals with regard to medical devices:
A) To repeal Royal Decree 1591/2009 of 16 October 2009 regulating medical devices, and Royal Decree 1616/2009 of 26 October 2009 regulating active implantable medical devices in view of the direct application of Regulation (EU) 2017/745 as of 26 May 2020.
B) To develop the regulatory measures required for the areas where the regulation has determined that it will be the Member States which will lay down the rules at national level.
C) To adapt, adopt or maintain the measures required by national legislation.
10. References to basic texts: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, from 26 May 2021
Royal Decree 1591/2009 of 16 October 2009 regulating medical devices
Royal Decree 1616/2009 of 26 October 2009 regulating active implantable medical devices
11. No
12. -
13. No
14. No
15. Yes
16. TBT aspect
NO - The draft will have no discernible effect on international trade.
SPS aspect
NO - The draft will have no discernible effect on international trade.
**********
European Commission
Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu
