Medtech Insight 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


EU recognises pivotal device standards:

This article was originally published in Clinica

Executive Summary

The titles of three key quality system standards for the medical device industry were published in the Official Journal of the European Communities on July 31. EN ISO 13485 and EN IS0 13488 are both internationally accepted medical device quality system standards that are intended to replace EN 46001 and EN 46002 in Europe. Their publication indicates that once manufacturers meet these requirements, they are presumed to be in conformity with the relevant requirements of the medical device directives. These earlier medical device quality system standards needed updating in the light of the publication in 2000 of the generic quality system standard, ISO 9001:2000, and become redundant on March 1 2004. Also published on July 31 is EN ISO 14971, a horizontal standard on the application of risk management to medical devices. This will supersede the European risk standard was EN 1441, which becomes redundant on April 1 2004.

You may also be interested in...

Cosmetic And Personal Care Trademark Review 24 November, 2020

Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.

CBD Health Benefits More Attractive To Women? FDA Prioritizes Research Into Utero Effects

Among the largest gaps in safety data is non-clinical research on CBD use's effect on developing fetus and adolescent brain, in utero/lactational exposure, reproductive toxicity and the potential for a latency period before toxicity, says FDA  neuroscientist Andrew Shen.

COVID-19 Serology Templates: FDA Updates Sponsor Template, Adds Home Test Document

The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.





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