European Commission

New EU medical device regulations cause industry shake up

Monday, August 21, 2017

Medical device manufacturers will need to provide substantially more clinical evidence to support claims of safety and performance for many medical and in vitro diagnostic (IVD) devices marketed in the European Union (EU) as the result of two new regulations adopted by the European Parliament.

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Exco InTouch receives privacy shield framework self-certification

Tuesday, January 17, 2017

ERT company Exco InTouch, a provider of digital patient engagement and data capture solutions for clinical research and healthcare providers, has formally received EU-U.S. Privacy Shield Framework Self-Certification status by the U.S. Department of Commerce’s International Trade Administration (ITA). The designation certifies that Exco InTouch’s practices meet or exceed the data privacy and security principles outlined by U.S. Department of Commerce and European Commission.

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The European Commission launches a public consultation on the Pediatric Regulation

Friday, November 18, 2016

The European Commission (EC) has launched a public consultation to get views and feedback from stakeholders, to support the Commission in drafting its second report on the Pediatric Regulation after nearly 10 years of implementation. The consultation is open until February 20, 2017. Stakeholders should send their comments directly to the EC by accessing the consultation page.

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