News

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…

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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