News
MDR and IVDR challenge: General obligations of the Manufacturer
The definition of Manufacturer means: ‘the natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under his name or trademark.’ In other words: the entity that markets the device with its name…
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…
The final text of the MDR and IVDR will be available on short notice!
Although preliminary MDR and IVDR requirements are well known by notified bodies for a long time, many challenges within these notified bodies can be identified. An important challenge is the internal capacity to serve their clients after the publication of the MDR and IVDR. A lack of clinical expertise and…
2017: MDR and IVDR challenge
2017 is going to be a memorable regulatory year within the medical device field. As we want to highlight a few major issues that will affect manufacturers of ALL medical device risk classifications Risk Class I medical devices and self-certifiable In Vitro Diagnostic devices(IVD): The era of Risk Class…
Revisited guideline for making a clinical investigation application under the Medical Device Directive (Meddev 2.7/2, revision 2)
(September 2015) This updated guideline Meddev 2.7/2 revision 2, includes nine new appendices to support the validation and assessment processes of clinical investigations. The updated guideline states that clinical investigations should generally be 'designed, conducted and reported' either in accordance with the EN ISO 14155 (Good Clinical Practice requirements for…
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…