Slide background
Slide background




FAQ - MDR Transitional provisions

ID 7853 | | Visite: 684 | Documenti Marcatura CE ENTIPermalink: https://www.certifico.com/id/7853

FAQ MDR Transitional provisions

FAQ - MDR Transitional provisions

Implementation of the new EU Medical Devices Regulations

The Competent Authorities for Medical Devices (CAMD) Executive Group recommended the establishment of an Implementation Taskforce for the new EU Regulations for Medical Devices (MDR) and in vitro Diagnostic Medical Devices (IVDR) to facilitate collaboration and cooperation within the medical devices network during the implementation phase of the new regulations.

The objective is to implement an effective, robust, predictable and secure regulatory system and ensuring better protection for public health in the medical devices sector. The taskforce is not intended to replace or prevent any national-specific implementation planning or activity that a competent authority wishes to conduct.

Following a decision at the May 2017 CAMD meeting in London, an additional group was established – the Transition Subgroup – with the remit of providing clarity on the transition provisions of the MDR and IVDR.
___________

MDR/IVDR Transition Subgroup

The MDR/IVDR Transition Subgroup has developed some FAQs to provide clarity.

The key objectives of the Transition Subgroup are to:

- identify areas with the potential for inconsistent application;
- troubleshoot issues and provide recommendations or clarity, in the form of a ‘questions and answers’ document, on interpretation;
- where appropriate, seek legal input to underpin proposals;
- where appropriate, recommend the development of procedures to ensure authorities implement in a consistent manner.

Contents:
I - Issue: Transition in general
II - Issue: Placing on the market of MDR compliant devices until 26 May 2020 (Art. 120 para 5-7 MDR)
III - Issue: Placing on the market of devices in conformity with the Directives after 26 May 2020 (Art. 120 para 2 -3 MDR)
IV - Issue: The so called “sell off” provision of Art. 120 para 4 MDR
V – Issue: EUDAMED and its relevance for the application of certain provisions of the MDR (Art. 123 para 3 d and e, Art. 120 para 8, Art. 122 MDR)

Glossary:
- AIMDD/MDD compliant device = device that is compliant with Directive 90/385/EEC/ Directive 93/42/EEC
- AIMDD/MDD certificates = certificates in accordance with Directive 90/385/EEC/ Directive 93/42/EEC
- DoA = date of application of the MDR
- MDR = Medical Device Regulation (EU) 2017/745
- MDR compliant device = device that is compliant with the MDR
- MDCG = Medical Device Coordination Group
- MFR = manufacturer
- PRRC = person responsible for regulatory compliance
- NB = notified body
- “old” NB = NB that has issued an AIMDD/MDD certificate
- The Directives = Directives 90/385/EEC, 93/42/EEC

CAMD 2018

https://www.camd-europe.eu/

Pin It
Scarica questo file (FAQ MDR 2018 v1.0.pdf)FAQ MDR 2018 v1.0 IT320 kB(71 Downloads)

Tags: Marcatura CE Abbonati Marcatura CE Regolamento Dispositivi Medici

Articoli correlati

Ultimi archiviati Marcatura CE

Verbali del gruppo di lavoro ATEX 1997 2018
Set 27, 2019 111

Verbali del gruppo di lavoro ATEX 1997-2018

Verbali del gruppo di lavoro ATEX 1997-2018 Update Settembre 2019 Consolidated minutes of the meetings of the working group of the ATEX Directives 94/9/EC and 2014/34/EU committee This document includes the consolidated minutes of the meetings held from October 1997 until February 2018 (37… Leggi tutto
Set 23, 2019 129

Circolare n. A00-09/0005411/08 del 10/11/2008

Circolare n. A00-09/0005411/08 del 10/11/2008 Apparecchi a pressione: scadenza per la denuncia di recipienti e tubazioni. L’11/2/2009 è la data ultima entro la quale i recipienti per liquidi e le tubazioni esistenti al 12/2/2005, commercializzati fino al 29/5/02 e non certificati PED, esclusi dalla… Leggi tutto
Set 06, 2019 154

Rettifica del regolamento (UE) 2016/1628 | 06.09.2019

Rettifica del regolamento (UE) 2016/1628 GU L 231/29 DEL 06.09.2019 Rettifica del regolamento (UE) 2016/1628 del Parlamento europeo e del Consiglio, del 14 settembre 2016, relativo alle prescrizioni in materia di limiti di emissione di inquinanti gassosi e particolato inquinante e di omologazione… Leggi tutto

Più letti Marcatura CE

Giu 26, 2019 46977

Regolamento Prodotti da Costruzione (UE) 305/2011 - CPR

Regolamento CPR (UE) 305/2011 Regolamento (UE) N. 305/2011 del Parlamento Europeo e del Consiglio del 9 marzo 2011 che fissa condizioni armonizzate per la commercializzazione dei prodotti da costruzione e che abroga la direttiva 89/106/CEE del Consiglio (Testo rilevante ai fini del SEE) GU L 88/10… Leggi tutto