2020-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 (…)
Most recent articles
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MIR 7.2 and its A to F completed annexes
21 January 2020, by MME -
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 (…) -
SWISS MEDTECH _ Worst Case scenario still realistic from today’s perspective
21 January 2020, by MMEMutual Recognition Agreement (MRA) Switzerland _ Europe
versus
Third-Country compliance for all products (MDR-MDD) from May 26, 2020 ?
As indicated in the information bulletin from Swiss Medtech dated December 11, 2019, concerning the Mutual Recognition Agreement (MRA), the interpretation of the current MRA is key for Swiss manufacturers.
Since last December, EU Commission lawyers have been interpreting the MRA in the most unfavourable way possible for Switzerland. Their position (…) -
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 (…) -
January 2020 MIR form rev 7.2 and its Annexes
5 January 2020, by MMEStarting January 01, 2020, the management of vigilance event made the use of a new form compulsory, which is so far MIR rev. 7.2.
And to use it, publishing was made too of an updated "Help Text" (list of Annexes A to F codes)
Starting January 01, 2020, the management of vigilance event made the use of a new form compulsory, which is so far MIR rev. 7.2.
As EUDAMED has been delayed, some sections are not yet available and are either prefilled (with "unknown") or left blank (…) -
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 -
DEKRA Germany becomes the first NB to be designated under IVDR
10 October 2019, by MMEDekra Germany is first notified body designated under IVDR
The designation of the first notified body to review in vitro diagnostics means manufacturers can start working toward certification by the May 2022 deadline.
Dear IVD-Partners,
Good news today for IVD manufacturers as we are learning Dekra Germany has become the very first notified body designated under IVDR.
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The designation of the first notified body to review in vitro diagnostics means manufacturers can start (…) -
UDI - One page memo
1 October 2019, by MMEMemorandum EU-UDIs (UDI-DI and UDI-PI) ; labelling
Dear Partners,
Attached in one page memo which we hope will be helpful regarding compliance with next EU-UDI requirements (starting May 2020 up to 2027!)
With our best regards,
MediMark Europe Team -
TÜV SÜD becomes the 5th NB notified for MDR
30 September 2019, by MMESeptember 2019
TÜV Rheinland (NB 0123) becomes fifth Notified Body to obtain designation under the EU MDR 2017/745 !
From NANDO website and page
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=EPOS_43445 ,
we can learn more about the designation of:
Body :
TÜV SÜD Product Service GmbH Zertifizierstellen
Ridlerstraße 65
80339 MÜNCHEN
Country : Germany
Phone : +49 (89) 50084261
Fax : +49 (89) 50084230
Email : (…)