Slide background
Slide background




EMA | Questions & Answers MD and In Vitro Diagnostic MD

ID 12505 | | Visite: 1328 | Documenti Marcatura CE ENTIPermalink: https://www.certifico.com/id/12505

Questions Answers MD and In Vitro Diagnostic MD

Questions & Answers MD and In Vitro Diagnostic MD

European Medicines Agency, Oct. 2019 / Update 

Update: EMA will update its regulatory guidance in the first quarter of 2021 to reflect the new date of application of the Regulation MD 26 May 2021.

Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)

Regulation (EU) 2017/745 application postponed from 26 May 2020 at 26 May 2021 from Regulation (EU) 2020/561.

1. Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)
2. Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes. This update of the questions and answers focuses on aspects relating to the implementation and applicability of the requirements of Regulation (EU) 2017/745 to medicinal products with an integral or co-packaged medical device.

This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations. This document has been produced to provide guidance to Applicants as regards aspects falling within the scope of the Agency’s activities and should be read in conjunction with the new medical devices Regulation (EU) 2017/745, and the new in vitro diagnostic medical devices Regulation (EU) 2017/746.

The medical devices regulation (MDR) and in-vitro diagnostics regulation (IVDR) replace the three existing Directives (93/42/EEC98/79/EC and 90/385/EEC) for medical devices.

The Regulations entered into force on 25 May 2017; however, they will have a transition period to allow manufacturers, notified bodies and authorities to comply with the changes and will come into full application on 26 May 2020  (postponed at 26 May 2021 from Regulation (EU) 2020/561) for medical devices and 26 May 2022 for in vitro diagnostics.

These regulations lay down roles and responsibilities for EMA and National Competent Authorities (NCA) for medicinal products, as follows:

- For medical devices incorporating a medicinal substance (with action ancillary to the device) the notified body shall seek a scientific opinion from either the NCAs or EMA. The notified body shall seek the opinion of EMA for medicinal products falling exclusively within the scope of centralized procedure , or that incorporate human blood or plasma derivatives
- For devices that are composed of substances or of combinations of substances that are systemically absorbed by the body in order to achieve their intended purpose, the notified body shall seek a scientific opinion from either the NCAs or the EMA
- For companion diagnostics, the notified body shall seek a scientific opinion from either the NCAs or the EMA
- The European Commission may consult EMA when deliberating on the regulatory status of products in borderline cases involving medicinal products
- For medicinal products with an integral medical device, there are new requirements to provide an opinion from a notified body

This is a living document and the questions and answers are being updated continuously, and will be marked by “NEW” or “Rev.” with the relevant date upon publication.

Table of contents
1. Medicinal product medical device combinations (‘combination products’)
1.1. What regulatory framework does a product incorporating both medicinal product and medical device fall under? New Oct 2019
1.2. How do I choose a notified body for my co-packaged /integral device? New Oct 2019
2. Medicinal product with an integral medical device (integral DDC)
2.1. When is my medicinal product considered to form an integral product with the administration device?
2.2. What is Article 117 and what does it mean for medicinal products? Rev. Oct 2019
2.3. How will the medical devices Regulation and in particular Article 117 impact new marketing authorisation applications? Rev. Oct 2019
2.4. When is it required to provide the notified body opinion/ EU certificate / declaration of conformity with my Marketing Authorisation Application (MAA)? Rev. Oct 2019
2.5. At what stage do I need to submit the notified body opinion?
2.6. How does Article 117 of the medical devices regulation impact currently authorised integral DDCs? Rev. Oct 2019
2.7. Will I need to provide a (new or updated) EU certificate / declaration of conformity / notified body opinion if there are changes to the device submitted through a variation /extension?
2.8. What is the impact of the MDR on medicinal products including an integral medical device for a Mutual Recognition Procedure submitted on or after the 26 May 2020? New Oct 2019.
2.9. Are the requirements for UDI (unique device identifier) applicable to integral DDCs? New Oct 2019
3. Medicinal product with a co-packaged device
3.1. How will the implementation of the Medical Device Regulation affect the device? New Oct 2019
...

Fonte: EMA

Collegati:

 

Tags: Marcatura CE Abbonati Marcatura CE Regolamento Dispositivi Medici Regolamento DMD Vitro

Ultimi archiviati Marcatura CE

Mar 20, 2023 51

Decreto 6 ottobre 2020

Decreto 6 ottobre 2020 Esclusione della pubblicita' dei profilattici dall'autorizzazione del Ministero della salute. (GU n.284 del 14.11.2020) [box-warning]Abrogato da: Decreto 26 gennaio 2023 Individuazione delle fattispecie di pubblicita' di dispositivi medici che non necessitano di… Leggi tutto
Mar 20, 2023 54

Decreto 23 febbraio 2006

Decreto 23 febbraio 2006 Pubblicita' dei dispositivi medici. (GU n.93 del 21.04.2006)
Abrogato da: Decreto 26 gennaio 2023 Individuazione delle fattispecie di pubblicita' di dispositivi medici che non necessitano di autorizzazione ministeriale. (GU n.66 del 18.03.2023)
Leggi tutto
Regolamento  UE  2023 607
Mar 20, 2023 238

Regolamento (UE) 2023/607

Regolamento (UE) 2023/607 / Modifica Reg. Dispositivi medici e DMD vitro ID 19258 | 20.03.2023 Regolamento (UE) 2023/607 del Parlamento europeo e del Consiglio del 15 marzo 2023 che modifica i regolamenti (UE) 2017/745 e (UE) 2017/746 per quanto riguarda le disposizioni transitorie per determinati… Leggi tutto
Regolamento delegato  2023 503
Mar 08, 2023 130

Regolamento delegato (UE) 2023/503

Regolamento delegato (UE) 2023/503 / Modifica Regolamento DMD Vitro ID 19171 | 08.03.2023 Regolamento delegato (UE) 2023/503 della Commissione del 1° dicembre 2022 che modifica il regolamento (UE) 2017/746 del Parlamento europeo e del Consiglio per quanto riguarda la frequenza delle nuove e… Leggi tutto
Regolamento delegato  2023 502
Mar 08, 2023 191

Regolamento delegato (UE) 2023/502

Regolamento delegato (UE) 2023/502 / Modifica Regolamento Dispositivi medici ID 19170 | 08.03.2023 Regolamento delegato (UE) 2023/502 della Commissione del 1° dicembre 2022 che modifica il regolamento (UE) 2017/745 del Parlamento europeo e del Consiglio per quanto riguarda la frequenza delle nuove… Leggi tutto
Feb 24, 2023 119

Decreto 29 settembre 2003

Decreto 29 settembre 2003 Individuazione delle funzioni e compiti degli uffici speciali per i trasporti ad impianti fissi (USTIF). (GU n.280 del 02.12.2003) Leggi tutto
Feb 24, 2023 102

Decreto 5 dicembre 2003 n. 392

Decreto 5 dicembre 2003 n. 392 Regolamento concernente modifica dell'articolo 7 del decreto del Ministro dei trasporti e della navigazione 4 agosto 1998, n. 400, recante norme per le funicolari aeree e terrestri in servizio pubblico destinati al trasporto di persone. (GU n.40 del… Leggi tutto

Più letti Marcatura CE