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


Updating Your Device In The EU? It Isn't Always Clear When You Need To Tell The Notified Body

Executive Summary

In the EU, when do manufacturers need to tell notified bodies about an extension to their product line before placing the updated devices on the market? Is there a definitive answer, or is more clarity needed? Experts weigh in.

You may also be interested in...

FDA Calls For Full Risk Reviews For Device Changes In 510(k) Modifications Draft

US FDA wants sponsors to complete risk-based assessments and thoroughly consider unintended outcomes of changes they make to already-cleared devices, says a new, highly anticipated draft guidance on 510(k) modifications. This is true whether alterations are made by manufacturers to improve safety or effectiveness, enhance labels, change technology or engineering, or to upgrade materials in a device.

A “Disastrous” Draft? Device Firms Take Issue With 510(k) Modifications Guidance

Draft guidance on when to submit a 510(k) for a change to a previously cleared device could increase the number of submissions by two- or three-fold, device makers say. Some call for draft to be withdrawn.

FDA Policy For Device Modifications Faces Mounting Scrutiny

Legislators looking for weak spots in FDA's device pre-market review program have honed in on a perceived loophole that allows firms to change existing 510(k) products without notifying FDA


Latest Headlines
See All



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