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


Europe In Brief

This article was originally published in The Gray Sheet

Executive Summary

European clinical evaluation guidelines: The European Commission in December issued revised 1clinical evaluation guidelines explaining how manufacturers should conduct and document clinical evaluations of devices both before and after putting them on the market. "The clinical evaluation is expected to address the significance of any risks that remain after design risk mitigation strategies have been employed by the manufacturer," the guidelines state. The document notes that the extent of clinical evaluation needed depends on the nature, classification, intended use and risks of the particular device. For many devices embodying incremental modifications, it will be possible to draw on clinical experience with and literature reports on the safety and performance of equivalent devices, the guidelines note. For other devices - such as high risk devices, devices based on technologies where there is little or no experience, or those that represent a new clinical use - clinical investigations are likely to be required. The new guidelines, entitled MEDDEV 2.7.1 Rev. 3, take effect March 21 (2"The Gray Sheet" Aug. 17, 2009). They apply to medical devices generally and the device component of combination products; they do not cover in vitro diagnostics

You may also be interested in...

Cert Of Conformity Questions Remain From EU Devices Directive Revisions

It is unclear whether companies will need to revise their existing certificates of conformity in order to comply with upcoming revisions to the Medical Device Directives in Europe, according to Hogan & Hartson attorney Elisabethann Wright

Chloroquine ‘Approval’ For COVID-19 And The US FDA’s New Reality

Asking whether FDA’s decision to allow emergency use of two old anti-malarial drugs was ‘political’ misses the point. The issue already was political, and FDA’s action may well be the best way to keep some measure of federal control on supplies of a drug with important other uses.

Biopharma, Payers Seek National Guidelines For Prescribing Potential COVID-19 Drugs

Guidelines for health care providers could help prevent shortages as demand for possible treatments surge, groups say. Stakeholders also argue “Buy America” executive order would hamper drug access.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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