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EU Regulatory Roundup, November 2018: 'Implant Files' Dominate, While Brexit/New Reg Issues Rumble On
The medtech sector was already quite overwhelmed with the new EU regulations and Brexit uncertainties. Now add into the mix the impact of the global journalistic Implant Files investigation.
Latest From Europe, Policy & Regulation
The UK government has been working on plans to ensure medical devices, among other goods, can still "flow into the country, and won't be delayed by additional controls and checks."
The European Commission must, like everyone, ensure that it complies with its responsibilities within the context of EU rules governing medical devices. A recent European Court ruling may open the door for companies to seek compensation from the European Commission for related failures. Two attorneys explain.
Market surveillance has historically been too fragmented around Europe, according to critics of the EU system, but the national authorities have been creating a new joint work program and are on the cusp of launching a new initiative.
There are fears that some countries may reject medical devices and IVDs that have been CE marked under the EU medical device directives, even though their registrations may still be valid. The European Commission is now trying to address this.
Nov. 25 was the halfway mark in the three-year transition toward full implementation of the new EU Medical Devices Regulation. It was also the day the International Consortium of Investigative Journalists (ICIJ) dropped a bomb on the medical device sector, and it has been shelling the industry every day since. How are key industry experts reacting?
The International Consortium of Investigative Journalists unleashed this week the conclusions of a yearlong investigation into the medtech industry that paint it in an unflattering light. ICIJ interviewed former German Social Democrat MEP Dagmar Roth-Behrendt, the initial rapporteur at the European Parliament on the EU's new Medical Device Regulation. See what she said here.
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