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

Spain’s Only Notified Body Sets Time Limits For New Customers And New Products

Executive Summary

The European Commission may well be optimistic that the new EU medtech Regulations can be implemented on time, but a second notified body has officially announced that it will have to turn new – and some existing clients' – work away, highlighting how the sector is buckling under the strain of work volumes.

You may also be interested in...



Spanish Medtech Gets Ad Approval Stamp, Looks To Rekindle Purchasing

Enhancing trust in medical devices and medtech companies is the aim of a new agreement between the Spanish medtech industry and an organization specializing in helping businesses meet and maintain high legal and ethical standards.

2023: A Bumpy Road Ahead For Implementation of Medtech Regulations

Originally intended to increase medical device safety, the EU’s medtech regulation is so hampered in its implementation that it is now arguably a bigger potential threat to patients than any of the scandals leading to its more stringent requirements.

Heads Of Medicines Agency Group Adds Another Authority Voice To Intense EU MDR Debate

EU member state authorities overseeing devices have been putting out a series of messages that promise action to ease the implementation chaos surrounding the EU’s new medtech regulations.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT125186

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