Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

BSI Gives Clients Until March 31 To Submit For Recertification Under EU Directives

Executive Summary

In an urgent notice to clients, notified body BSI warns that time is running out to recertify against the current EU directives, as pressures mount for all notified bodies.

You may also be interested in...



35 Notified Bodies In The Pipeline – But Heading For Catastrophe With Tight Timing?

New survey results suggest there could be a drop of about 40% in the number of EU notified bodies testing medical devices. A rough calculation points to an even bigger potential drop in the number that will be ready in time, when the Medical Device Regulation fully applies in 2020. A close look at newly available data signals the prospect for a serious bottleneck.

UK Brexit White Paper Would Keep Medtech Regulatory System – And Testing Just Once – Intact

It looks as if the EU medtech regulatory system could survive intact in the UK, given terms of the UK blueprint for its future relationship with the EU after separation. But a storm of controversy must be navigated first.

EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency

Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT123067

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel