Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
The recent document from the European Commission's Medical Devices Coordination Group concerning device registration timelines is difficult to follow, with its many unexplained references. This article aims to clarify how the MDCG's findings affect the way manufacturers should prepare for MDR compliance.
Latest From Europe, Policy & Regulation
The number of EU notified bodies applying for designation against the EU MDR has risen by over a third in the past nine months, the European Commission reports. IVDR applicant numbers are up slightly too. But are the increases enough to ease the anticipated bottlenecks?
With just over 13 months until the EU Medical Devices Regulation is fully applicable, EU medtech manufacturers are imploring the European Commission to speed readiness of the new regulatory system or patients and industry will suffer.
The new EU medical device regulations ̶ the MDR and IVDR – left a gap in how manufacturers of legacy products should comply with critical reporting requirements. A solution has been found.
Has the European Commission done enough to allow UK-certified medical devices to continue on the EU27 market in the event of the UK dropping out of the EU without a deal – a possibility that remains very real?
The price versus quality standoff surrounding the supply of medtech aids and assistive-care products prescribed in the German primary- and ambulatory-care settings goes on. A ban on tenders, which can imbalance the market with large supplies of lower-quality imports, has soothed industry’s frustrations, but the battle is not over yet.
Will Eudamed, the European Database for Medical Devices, offer a free source of information for competitors which disadvantages original companies? Vincenzo Salvatore of international law firm BonelliErede highlights how the legal gap around the further utilization of data may be detrimental to some and advantageous to others.
All set! This article has been sent to firstname.lastname@example.org.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.