Notification Detail
Decree-Law ensuring the implementation in the internal legal order of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
Notification Number: 2021/130/P (Portugal )
Date received: 01/03/2021
End of Standstill:
02/06/2021
Issue of comments by:
Commission
| Message 002
Communication from the Commission - TRIS/(2021) 00794 Directive (EU) 2015/1535 Translation of the message 001 Notification: 2021/0130/P 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: 202100794.EN) 1. Structured Information Line MSG 002 IND 2021 0130 P EN 01-03-2021 P NOTIF 2. Member State P 3. Department Responsible Ministério da Economia Instituto Português da Qualidade Rua António Gião, 2 2829-513 Caparica Telefone: + 351 21 294 81 00 Fax: + 351 21 294 82 23 e-mail: not1535@ipq.pt site: www.ipq.pt 3. Originating Department Ministério da Saúde Autoridade Nacional do Medicamento e Produtos de Saúde I.P., Parque da Saúde de Lisboa – Av. do Brasil, 53, 1749-004 Lisboa Telefone: +351 217 987 100 Fax: +351 217 987 316 e-mail: infarmed@infarmed.pt site www.infarmed.pt 4. Notification Number 2021/0130/P - S10S 5. Title Decree-Law ensuring the implementation in the internal legal order of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices 6. Products Concerned Medical devices, medical device accessories and non-medical products listed in Annex XVI to Regulation (EU) 2017/745. 7. Notification Under Another Act - 8. Main Content The draft Decree-Law aims to lay down the rules necessary for the implementation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, accessories to medical devices and non-medical products listed in Annex XVI to that Regulation. This legislative proposal includes 73 articles comprising, in summary: subject matter; scope of application; competent authority and its powers; specialised committee; activities relating to devices such as manufacturing, custom manufacturing, manufacturing and use by and in health institutions, use, codification, distribution, marketing and advertising; notified bodies; surveillance; some common provisions concerning general obligations, costs of acts and services and language; inspection and supervision rules, which include the penalty regime applicable in the event of infringement of the Regulation and the Decree-Law itself; and final and transitional provisions. Thus, this Act constitutes the legal framework which, at the same time, takes into account the necessary implementation of Regulation (EU) 2017/745 and the national paradigm as regards the entire circuit of devices, respecting the primacy of Community law and the protection of public health and safety of users/patients. Key words: device, manufacture, coding, distribution, advertising, notification, registration, surveillance, supervision. 9. Brief Statement of Grounds This draft Decree-Law aims to define the measures necessary for the implementation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, accessories to medical devices and non-medical products listed in Annex XVI to that Regulation. It also aims to regulate other aspects relating to devices, in particular specificities relating to manufacturing, such as custom manufacturing and the manufacture and use by health institutions, requirements relating to the registration of different economic operators, advertising, national surveillance system, and penalty regime. Thus, this Act constitutes the legal framework which, at the same time, takes into account the necessary implementation of Regulation (EU) 2017/745 and the national paradigm as regards the entire circuit of devices, respecting the primacy of Community law and the protection of public health and safety of users/patients. 10. Reference Documents - Basic Texts No basic text(s) available 11. Invocation of the Emergency Procedure No 12. Grounds for the Emergency - 13. Confidentiality No 14. Fiscal measures No 15. Impact assessment - 16. TBT and SPS aspects TBT aspect No - the draft is compliant with an international standard. MSF aspects No - the draft is neither a sanitary nor phytosanitary measure. ********** European Commission Contact point Directive (EU) 2015/1535 Fax: +32 229 98043 email: grow-dir2015-1535-central@ec.europa.eu |
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