Introduced by the Lisbon Treaty, Implementing and Delegated Acts are a new source of European law. Disciplined respectively by Articles 290 and 291 of the TFEU, they aim to improve the effectiveness of the European decision-making process by simplifying the implementation/execution procedure. This study investigated the Implementing and Delegates Acts pertinent to EU Regulation 745/2017 on medical devices. Although complicated by the fact that these Acts are issued at different times and with different modalities following the entry into force of the Regulation to which they refer, our research was facilitated by the Eur-Lex database. Data extrapolation was followed by careful analysis of each Act and the creation of Tables with succinct but comprehensive summaries in chronological order. The result is an updated overview of a complex ongoing regulatory process. While eight Implementing Acts pursuant to Art 35, 27.2, 106.17, 10.6, 33.8, 5.6, 10.6 of the MDR have been introduced by the Commission at different times, none of the twelve Delegated Acts referred to in Article 115 of the Regulation has yet been forthcoming. Unlike Implementing Acts, Implementing Decisions n. 2021/1182 and 2022/6 stand out for their clarity, with the specific ISO regulation on medical devices official acknowledged as a binding requirement. - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.) https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=celex:32017R0745#:~:text=Regolamento% 20(UE) 2017% 2F745,rilevante ai fini del SEE. ) - Consolidated version of the Treaty on the Functioning of the European Union https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:12012E/TXT:it:PDF - C. Rivadossi, Il TFUE e le nuove fonti del diritto dell’Unione Europea. Atti delegati e Atti di esecuzione a confronto, 12 ottobre 2014, Cattedra di diritto pubblico, Università di Brescia. https://www.forumcostituzionale.it/wordpress/wp-content/uploads/2013/05/rivadossi.pdf - J. Mendes, Delegated and Implementing Rule Making: Proceduralisation and Consultation De-sign, European Law Journal, Vol. 19, No. 1, January 2013, pp. 22–41 - European Commission, questions and answers European nomenclature of medical devices https://ec.europa.eu/health/system/files/2021-10/md_q-a_emdn_it_0.pdfo - European Standardization https://www.cencenelec.eu/european-standardization/ - https://ec.europa.eu/info/law/law-making-process/adopting-eu-law/implementing-and-delegated-acts_it - Comitology https://ec.europa.eu/info/law/law-making-process/adopting-eu-law/implementing-and-delegatedacts/comitology_it - https://eurlex.europa.eu/search.html?SUBDOM_INIT=ALL_ALL&DTS_SUBDOM=ALL_ALL&DTS_DOM=ALL&lang=en&type=advanced&DB_IMPLEMENTING=32017R0745&qid=1636408561747 - https://eurlex.europa.eu/search.html?SUBDOM_INIT=ALL_ALL&DTS_SUBDOM=ALL_ALL&DTS_DOM=ALL&DB_DELEGATED=32017R0745&lang=en&type=advanced&qid=1636408628734rire testo
Elisa Rocchi, Guido Argenta, Giorgia D'Orazio, Gian Maria Rossi, Lucia Savadori, Federica Bigucci, et al. (2022). LANDSCAPE REVIEW OF IMPLEMENTING AND DELEGATED ACTS APPLICABLE TO EUROPEAN MEDICAL DEVICE REGULATION 745/2017.
LANDSCAPE REVIEW OF IMPLEMENTING AND DELEGATED ACTS APPLICABLE TO EUROPEAN MEDICAL DEVICE REGULATION 745/2017
Federica Bigucci;Maurizio Cini;Patrizia Rampinelli
2022
Abstract
Introduced by the Lisbon Treaty, Implementing and Delegated Acts are a new source of European law. Disciplined respectively by Articles 290 and 291 of the TFEU, they aim to improve the effectiveness of the European decision-making process by simplifying the implementation/execution procedure. This study investigated the Implementing and Delegates Acts pertinent to EU Regulation 745/2017 on medical devices. Although complicated by the fact that these Acts are issued at different times and with different modalities following the entry into force of the Regulation to which they refer, our research was facilitated by the Eur-Lex database. Data extrapolation was followed by careful analysis of each Act and the creation of Tables with succinct but comprehensive summaries in chronological order. The result is an updated overview of a complex ongoing regulatory process. While eight Implementing Acts pursuant to Art 35, 27.2, 106.17, 10.6, 33.8, 5.6, 10.6 of the MDR have been introduced by the Commission at different times, none of the twelve Delegated Acts referred to in Article 115 of the Regulation has yet been forthcoming. Unlike Implementing Acts, Implementing Decisions n. 2021/1182 and 2022/6 stand out for their clarity, with the specific ISO regulation on medical devices official acknowledged as a binding requirement. - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.) https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=celex:32017R0745#:~:text=Regolamento% 20(UE) 2017% 2F745,rilevante ai fini del SEE. ) - Consolidated version of the Treaty on the Functioning of the European Union https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:12012E/TXT:it:PDF - C. Rivadossi, Il TFUE e le nuove fonti del diritto dell’Unione Europea. Atti delegati e Atti di esecuzione a confronto, 12 ottobre 2014, Cattedra di diritto pubblico, Università di Brescia. https://www.forumcostituzionale.it/wordpress/wp-content/uploads/2013/05/rivadossi.pdf - J. Mendes, Delegated and Implementing Rule Making: Proceduralisation and Consultation De-sign, European Law Journal, Vol. 19, No. 1, January 2013, pp. 22–41 - European Commission, questions and answers European nomenclature of medical devices https://ec.europa.eu/health/system/files/2021-10/md_q-a_emdn_it_0.pdfo - European Standardization https://www.cencenelec.eu/european-standardization/ - https://ec.europa.eu/info/law/law-making-process/adopting-eu-law/implementing-and-delegated-acts_it - Comitology https://ec.europa.eu/info/law/law-making-process/adopting-eu-law/implementing-and-delegatedacts/comitology_it - https://eurlex.europa.eu/search.html?SUBDOM_INIT=ALL_ALL&DTS_SUBDOM=ALL_ALL&DTS_DOM=ALL&lang=en&type=advanced&DB_IMPLEMENTING=32017R0745&qid=1636408561747 - https://eurlex.europa.eu/search.html?SUBDOM_INIT=ALL_ALL&DTS_SUBDOM=ALL_ALL&DTS_DOM=ALL&DB_DELEGATED=32017R0745&lang=en&type=advanced&qid=1636408628734rire testoI documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
