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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…

EU joint Market Surveillance Project 2014 - 2020

(June 19, 2015) The European Commission (EC) has market surveillance on its list of priorities. The Competent Authorities for Medical Devices (CAMD) group recognizes that there is a lot of merit in member states (MS) working together on market surveillance. Advantages of collaborative working are the power of rolling out…

ISO 13485 (ISO/TC 210)

 (June 11, 2015) It is expected that the Final DIS (FDIS.2) of the ISO 13485:201x will be approved during the ISO/TC 210 WG1 meeting scheduled in November 14-20, 2015 (Denver, US). So, final publication of the medical device ISO 13485 scheme will be properly somewhere in Q1/2016. There’s good and…
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