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IVDR Transition Timelines Extended

Regulation (EU) 2024/1860 was published on June 9, 2024, in the Official Journal of the European Union (OJEU) with immediate effect. The amending Regulation provides extra time to conduct the conformity assessment of IVD’s needed for a CE certificate or an issued DoC. This Amending Regulation extends the IVDR transition…

UKRP-services

  The UK medical device regulatory system is independent of the European Economic Area (EEA). All medical device manufacturers will need to follow UK laws for (in vitro) medical devices, based on the EU regulations EU-MDR 2017/745 and EU-IVDR 2017/746. All non-UK manufacturers must have a UK-based UK Responsible Person…

BREXIT impact

How medical devices are currently regulated All medical devices are subject to EU legislation, which requires a manufacturer to place a CE mark on their product to attest compliance to applicable standards. Medical devices are regulated under Directive 90/385/EEC on active implantable medical devices (AIMDD), Directive 93/42/EEC on medical devices…

MDR and IVDR finally published (May 4th, 2017)

European Medical Device Regulations 2017/745 (MDR) and In Vitro Diagnostic Regulations 2017/746 (IVDR) are published May 5, 2017 in the Official Journal of the European Union (OJEU), May 4th, 2017. The MDR will replace the Active Implantable Medical Devices Directive (AIMD 90/385/EEC) and the Medical Devices Directive (MDD 93/42/EC), while…

Notified Body TuV Rheinland must pay 60 mio euro (64 mio USD)

January 21, 2017 A French court ordered European Notified Body TUV to pay 60 million euros ($64 million) in compensation to 20,000 women who received defective breast implants that the group had approved. TUV Rhineland was ordered to make a provisional payment of 3,000 euros to each plaintiff for certifying…

Independent Authorized Representatives facing additional liabilities

 (June 19, 2015) Following the public availability of the compromise Council position on the new medical device regulation, discussed and approved at the 19 June 2015 EPSCO meeting - unless further changes are made during the trialogue process - Authorized Representatives (AR's) who are independent from the supply chain now…
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