Medical devices law — new provisions concerning notified bodies

By Wolfgang von Rehmann

The European Commission published on 24 September the Implementing Regulation (EU) No 920/2013 on the designation and the supervision of notified bodies under the Council Directive 90/385/EEC on active implantable medical devices and the Council Directive 93/42/EEC on medical devices. On the same day, the commission also published a recommendation on the audits and assessments performed by notified bodies in the field of medical devices.

The provisions proposed by the commission in its regulation target better supervision of the accreditation bodies, and in particular of the notified bodies to be monitored by them, in the pursuit of their activities, the standardisation of examination standards and an improved exchange of information between the competent agencies and authorities at both the national and EU level in consultation with the commission.

The commission also proposes recommendations to the notified bodies on performing conformity assessment procedures. The measures are intended to improve supervisory and safety standards in the examination and monitoring of medical devices. They are also meant to create the transparency required to further develop safety standards on the basis of the findings and experiences at the community level and to ensure EU-wide uniform implementation…

If you are registered and logged in to the site, click on the link below to read the rest of the Taylor Wessing briefing. If not, please register or sign in with your details below. 

Sign in or Register to continue reading this article

Sign in

Register

It's quick, easy and free!

It takes just 5 minutes to register. Answer a few simple questions and once completed you’ll have instant access.

Register now

Why register to The Lawyer

 

Industry insight

In-depth, expert analysis into the stories behind the headlines from our leading team of journalists.

 

Market intelligence

Identify the major players and business opportunities within a particular region through our series of free, special reports.

 

Email newsletters

Receive your pick of The Lawyer's daily and weekly email newsletters, tailored by practice area, region and job function.

More relevant to you

To continue providing the best analysis, insight and news across the legal market we are collecting some information about who you are, what you do and where you work to improve The Lawyer and make it more relevant to you.

Briefings from Taylor Wessing

View more briefings from Taylor Wessing

Analysis from The Lawyer

  • merger deal

    Corporate crunch time: who will triumph at The Lawyer Awards 2014?

    As the equity capital markets rocketed back into favour and global M&A saw at least a partial return to form, there have been some rich pickings for The Lawyer’s Corporate Team of the Year award shortlisted firms in 2014. 

  • singapore orchid

    Singapore: Cash course

    The city-state is working hard to become a global wealth management hub, and law firms are gearing up for a prosperous new world

View more analysis from The Lawyer

Overview

5 New Street Square
London
EC4A 3TW
UK
http://www.taylorwessing.com

Turnover (£m): 241.20
No. of lawyers: 860 (UK 200)
Jurisdiction: UK
No. of offices: 4
No. of qualified lawyers: 67 (International 50)

Jobs