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Ukraine's EU-aligned medtech regulatory system, using notified bodies and manufacturers' Declarations of Conformity (DoC), came into effect on July 1. The state retains a role in surveillance, but it no longer controls medtech registration; companies must now comply with three technical regulations (akin to the EU medical device directives) to access the medtech market in Ukraine.
Latest From Europe, Policy & Regulation
The new MDR and IVDR were drafted with highest interests of EU patients in mind, but they may yet have a devastating effect on the EU's speedy access to innovation in general, and on medtech SMEs in particular. That is the view of one Swiss medtech CEO; he also has grave concerns about the loss of EU notified bodies and the impact on manufacturers.
It might seem that the Eurasian Economic Union (EAEU) agreement on medical device regulation is nothing but administrative issues and slow progress, but it should deliver benefits to all stakeholders after launch, currently slated for 2022. but manufacturers need to be mindful of the member states' strengths and weaknesses when selecting their reference member state.
The transition deadline for adoption of Eurasian Economic Union (EAEU) medtech principles across the five member states remains the end of 2021, but vital elements are still not resolved, giving rise, for the first time, to notions of a delay in adoption. This would be the pragmatic course, local market experts believe, but for now, efforts are aimed at completing the system on time.
Want to know more about medtech regulatory efforts in countries from Singapore to Myanmar to Russia, and more in between? In this week's podcast, Ashley Yeo provides an update from his reporting on what governments in the Asia and Eurasia regions are doing to focus oversight on devices and diagnostics. The short answer: A lot.
Think of the Russian regulatory system as an iceberg – there is more to it than meets the eye, and medtech applicants must keep a keen look out to ensure they are compliant in every aspect of a submission. Russian market controls of already-launched products are also on the rise.
EU Medtech Ecosystem Will Suffer Unless Notified Body Workload Concerns Are Addressed – The German View
An EU notified body redesignation rate of 10 per year is too slow. It won't help small companies using the new Medical Device and IVD Regulation systems, and is leaving NBs feeling let down and with a mountain to climb. A German industry group weighs in on the need to speed up redesignations.
Latest From Europe & Quality Control
'Perfect Storm' Arrives: Clock Ticking For Device Firms To Conform To ISO 13485, MDSAP, EU & ASEAN Regs
Device manufacturers that haven't begun conforming to various ongoing international regulatory changes are behind the 8-ball and risk noncompliance, industry insider Kim Trautman says.
Members of the TEAM-NB association, which account for about half of the anticipated future force of EU medtech notified bodies, are taking a coordinated approach to applying for redesignations against the new EU Medical Device and IVD Regulations. Will they succeed?
An Auditor's Take: Unrealistic EU Demands Are Causing Notified Body Exodus, Potential Company Collapses
Demands related to auditor education, experience and affiliation are making it difficult for notified bodies to retain and hire staff. This comes on top of much tougher regulatory requirements. One notified body auditor explains why the situation might be killing notified bodies when they are needed most.
Europe-based device companies should look to the experience of the implementation of Unique Device Identification in the US to prepare for the upcoming UDI mandate in the EU, Steve Cottrell and Madris Tomes explain in this guest column.
FDA finds QS and marketing violations at a host of international device-makers. FDA released warning letters to 14 device companies this week.
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