2024-10-23] For weeks, pressure has been mounting, particularly among the professional associations of medical device manufacturers, to ask the European Commission to take urgent measures to revise the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR). German MEP (and doctor) Peter Liese, with the active contribution of Dutch lawyer Erik Vollebregt, has launched an initiative to convince the European authorities to adopt (…)
MME News
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2024-11-08 EU Parliament adopted a resolution for an Urgent need to revise the medical devices regulations
8 November, by Rene Clement -
VIGILANCE forms and annexes - May 2020 releases
15 June 2020, by MMEMay 01, 2020 - Changes in Manufacturer Incident Reporting
MIR rev. 7.2.1 release.
January 2020 "Help Text" (list of Annexes A to F codes) is still applicable,
but Annex G (components) has also been released from IMDRF website last May.
Starting January 01, 2020, the management of vigilance event made the use of a new form compulsory, which was so far MIR rev. 7.2.
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First revision of this form was released last May 2020 under the name of MIR 7.2.1. .
The current version of (…) -
MDCG Guidances releases
15 June 2020, by MMELatest releases - MDCG Guidances from DOC ROOM EUROPE
Dear Members,
.
Here are thereafter and attached in PDF format four MDCG (not binding) guidances released last May and June 2020, regarding subjects you might find of interest.
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May 2020
MDCG 2020-11 - Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission (…) -
May 19, 2020 - Official Journal of the European Union
27 May 2020, by MMEOfficial Journal of the European Union 2020 | C 171 | 1 May 19, 2020
COMMUNICATION FROM THE COMMISSION Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745 (2020/C 171/01)
Integral article of the Official Journal of the European Union, dated May 19th, 2020
COMMUNICATION FROM THE COMMISSION
Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of (…) -
Mid April 2020 - MDCG Guidances release
8 May 2020, by MMEApril 15 - MDCG Guidances
Dear Members,
Here are thereafter and attached in PDF format four MDCG (not binding) guidances released last mid April regarding subjects you might find of interest.
2020-04-23 05 MDCG 2020-5 Guidance on Clinical Evaluation - Equivalence available from https://ec.europa.eu/docsroom/docum...
2020-04-23 06 MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices available from https://ec.europa.eu/docsroom/docum...
2020-04-24 MDCG (…) -
MIR 7.2 and its A to F completed annexes
21 January 2020, by MME2020-January
VIGILANCE _ MIR 7.2 and its A-to-F complete annexes
Dear Vigilance Teams Members,
The use of the 7.2 revision of the MIR posted last year on the European Commission website has become compulsory last January 01, 2020.
Coding is still quite new in Europe ; but complete A-to-F-annexes "helptext" has been released too. It is available in an xlxs format from the website : https://ec.europa.eu/docsroom/documents/33465 .
A stress is made already on the use of IMDRF coding (…) -
2020-01 More about The European Medical Device Nomenclature (EMDN)
21 January 2020, by MMEVery first elements of the EMDN (European Medical Device Nomenclature)
The European Medical Device Nomenclature (EMDN)
The European Medical Device Nomenclature (EMDN) will be the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database.
Founded on pre-established criteria and requirements (1) and based on orientations provided by the Medical Device Coordination Group (MDCG), the European Commission decided in favour of the use of the (…) -
End 2019 - NB notified for MDR and IVDR
21 January 2020, by MMEEnd 2019 Final Stage of designations in NANDO - 9 NBs designations were published for MDR and 3 NBs for IVDR
Notified Bodies are responsible for assessing medical devices (MDs) and diagnostics (IVDs). They are an indispensable part of the regulatory system since they grant a CE mark to each device before it can be placed in the EU market. Both new regulations, MDR 2017/745 and IVDR 2017/746, haved introduced new obligations for Notified Bodies and require the assessment of more (…) -
MDR Eu-UDI summary
17 October 2019, by MMEMDR European UDI summary by BSI
Dear Partners,
Please find here attached a summary of the European UDI process,
– From UDI-DI that will have to feature on DoC asap,
– and be obtained even for "Legacy Devices" within EUDAMED gets live (any vigilance event shall concern a device with its UDI to be able to reported for instance) ;
– till labelling and UDI on devices times.
Hoping it will be of help to you, We remain at your disposal for any question you may have on these topics. (…) -
2019-10-10 IVDR-MDR NB Designation to date
10 October 2019, by MMEAt the best of our knowledge, today, October 10th : IVDR-MDR_NB designation
Dear Partners,
Just a one-page shot document here attached to point out the status up to date October 10th, 2019, of the NB designated by NANDO for IVDR and MDR devices certifications.
With 5 MDR NBs, and 1 IVDR NB designated today (also designated for MDR by the way).
With our best regards,
MediMark Europe Team