2019年 10月 8日

New European MDCG guidance on MDR Summary of Safety and Clinical Performance (SSCP) rules

New European MDCG guidance addresses SSCP requirements
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2019年 9月 27日

TÜV Rheinland becomes fifth Notified Body to obtain designation under the EU MDR

Germany’s TÜV Rheinland has received designation to issue CE Mark certificates under the European Medical...
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2019年 9月 24日

RAPS recap: Compliance issues for compiling Clinical Evaluation Reports

2019 RAPS Convergence conference examined issues such as CER and clinical data management challenges
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2019年 9月 11日

European MDR covers cosmetic and aesthetic products: Are these firms ready?

Cosmetic products will need CE Marking to be commercialized in Europe
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2019年 8月 20日

IMQ becomes fourth Notified Body designated to MDR

Last week there were already some rumors about Instituto Italiano del Marchio di Qualita S.P.A...
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2019年 8月 14日

DEKRA obtains Notified Body designation for European Medical Devices Regulation

DEKRA Certification GmbH, NB number 0124, is now designated for the Medical Devices Regulation (EU)...
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2019年 7月 24日

New European MDR guidance on medical device implant cards

The European Medical Device Coordination Group (MDCG) has adopted a guidance document on implant cards,...
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2019年 7月 18日

State of flux: European Notified Body numbers decrease further ahead of MDR, IVDR

NB capacity to support CE Mark certification under current Directives, future Regulations squeezed further.
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2019年 7月 17日

European Commission clarifies medical device vigilance requirements

Further details related to MEDDEV 2.12-1 rev. 8 under the European Medical Devices Directive (MDD).
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2019年 6月 28日

La Commission européenne prévoit d'éventuelles ruptures d'approvisionnement dues au RIM et au RDIV

La Commission reconnaît les préoccupations du secteur relatives à une pénurie de dispositifs et à la capacité des organismes notifiés
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