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Additional guidance released _ Vigilance
Vigilance reporting : Latest release to provide further guidance to the use of new MEDDEV forms to be used no later than Jan 01, 2020Dear Partners and Vigilance teams members,The EU commission recently...
View ArticleAugust 21st Update - NANDO and MDR Notified bodies
August 21st 2019 - Latest news from NANDO concerning future "MDR-NB".Dear Partners,We've just learned this morning that, August 20th, NANDO had designated a fourth Notified BodyHere is the link to...
View ArticleManufacturers of Reusable Surgical Instruments: BSI Launches Urgent Appeal
Manufacturers of Reusable Surgical Instruments: BSI Launches Urgent Appeal : submission of applications regarding TF for 1R MD to be received within November 01, 2019Dear Partners and Manufacturers of...
View ArticleNew article
September 2019TÃœV Rheinland (NB 0123) becomes fifth Notified Body to obtain designation under the EU MDR 2017/745 !From NANDO website and pagehttps://ec.europa.eu/growth/tools-d... ,we can learn more...
View ArticleUDI - One page memo
Memorandum EU-UDIs (UDI-DI and UDI-PI) ; labellingDear Partners,Attached in one page memo which we hope will be helpful regarding compliance with next EU-UDI requirements (starting May 2020 up to...
View ArticleDEKRA Germany becomes the first NB to be designated under IVDR
Dekra Germany is first notified body designated under IVDRThe designation of the first notified body to review in vitro diagnostics means manufacturers can start working toward certification by the May...
View Article2019-10-10 IVDR-MDR NB Designation to date
At the best of our knowledge, today, October 10th : IVDR-MDR_NB designationDear Partners,Just a one-page shot document here attached to point out the status up to date October 10th, 2019, of the NB...
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MDR Eu-UDI summary
MDR European UDI summary by BSIDear 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...
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End 2019 - NB notified for MDR and IVDR
End 2019 Final Stage of designations in NANDO - 9 NBs designations were published for MDR and 3 NBs for IVDRNotified Bodies are responsible for assessing medical devices (MDs) and diagnostics (IVDs)....
View ArticleSWISS MEDTECH _ Worst Case scenario still realistic from today's perspective
Mutual 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...
View Article2020-01 More about The European Medical Device Nomenclature (EMDN)
Very 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...
View ArticleMIR 7.2 and its A to F completed annexes
2020-January VIGILANCE _ MIR 7.2 and its A-to-F complete annexesDear Vigilance Teams Members, The use of the 7.2 revision of the MIR posted last year on the European Commission website has become...
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2020-02-06 NBs Update - NANDO and MDR-IVDR NBs
DNV GL Presafe (2460), Norway is notified by NANDO to MDR 2017/745DNV GL Presafe (2460) in Norway is the 10th notified body certified to the MDR 2017/745. DNV GL Presafe AS in Norway was notified...
View Article2020-02- NANDO NBs Update - NSAI 0050
Designation by NANDO of NSAI as MDR NBSource : https://ec.europa.eu/growth/tools-d...National Standards Authority of Ireland (NSAI) 1 Swift Square, Northwood, Santry Dublin 9 Country : IrelandPhone :...
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March 2020 - NANDO designated NBs MDR-IVDR
March 2020 Update of the list of Notified Bodies accredited by NANDO for MDR and IVDRMDR : 12 Notified Bodies..Specific fields for accredition can be found on NANDO website (hlm and PDF are available)...
View ArticleLast 2020 releases _ April 8th, 2020
Last 2020 publications (updated April 08th, 2020)All MDCG guidances already published shall soon be available in this specific section.These guidances are not binding guidelines (compared to MDR...
View ArticleAll MDCG guidances...
EU "Doc Room"Website of the EU "Doc Room"where all MDCG (not binding) guidances can be re-found, published in reverse chronological orderhttps://ec.europa.eu/docsroom/docum...
View Article2020 April 08th release - MDCG 2020-4
MDCG 2020-4 : NB Audits and COVID-19 quarantine (not binding guidance) - MDCG Guidances
View ArticleDEKRA Germany becomes the first NB to be designated under IVDR
Dekra Germany is first notified body designated under IVDRThe designation of the first notified body to review in vitro diagnostics means manufacturers can start working toward certification by the May...
View Article2019-10-10 IVDR-MDR NB Designation to date
At the best of our knowledge, today, October 10th : IVDR-MDR_NB designationDear Partners,Just a one-page shot document here attached to point out the status up to date October 10th, 2019, of the NB...
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