Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Clinical investigations standard cannot yet be argued as proof of conformity with EU directives

This article was originally published in RAJ Devices

Executive Summary

Manufacturers who meet ISO 14155:2011, the new international standard on clinical investigations for medtech products, would not be considered as having conformed with EU medical device directives as the standard has not yet been harmonised in the legislation.

You may also be interested in...



European Parliament To Vote On MDR Delay As Council Rectifies Critical Mistake

The EU is pulling out all the stops to have the one-year delay to the MDR adopted before it is too late, and a crucial vote will take place on 16 April.

Guidance Clarifies EU Position On Alternatives To Notified Body On-Site Audits

Virtual notified body audits of medtech manufacturers are already taking place through necessity. Now there is guidance concerning if, when, where and how these audits should be carried out.

Drug/Device Combinations: New Position Paper Explains Notified Body Responsibilities

Medicinal products authorities will consider a medtech notified body opinion on the device element of a drug/device combination product. A new position paper explains how roles and responsibilities are shared between medtech and medicinal product experts.

UsernamePublicRestriction

Register

SC096763

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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