The European Association of Notified Bodies for Medical Devices have published a paper questioning the auditing process for Authorized Representatives.
News
The EU Regulation 722/2012 on utilizing tissues of animal origin
The new EU regulation for medical devices comes into force in August 2012. It contains a number of changes for devices containing tissue of animal origin.
Review of Press Conference on NEW Proposals of European Medical Device Legislation
Further reading on the European Commission's press conference on proposed changes to European medical and in-vitro diagnostic device legislation.
New lists of harmonized standards for medical devices published by EU Commission
European Commission has released a new list of harmonized standards for medical devices on the European market. Learn more about the new important updates.
New Amendment to the Cosmetic Product Directive (referring to hair dying products)
New changes have been made to directive 76/768/EEC annexes to allow for new knowledge and practices in hair dying products, formulation, and notification.
New WEEE Directive’s Affects on Medical Devices
The updated Waste Electrical & Electronic Equipment directive places new obligations on medical devices in the EU. Find out how to reach compliance with Obelis.
Stricter labelling principles for sunscreens in Europe
A new EU Commission recommendation, in line with 2006/647/EC) mandates the standardization of claims and labelling for sunscreen products on the EU market.
Early Implementation of an EU Vigilance Portal
The proposed new EU medicines and medical device vigilance portal – EUDAMED – aims to increase oversight and incident reporting systems throughout Europe.
Revision of the IEC 60601-1 Regarding Medical Devices, 3rd Edition
The 3rd edition revision of IEC 60601-1 for medical devices in Europe will come into effect in June 2012. Learn more about EU harmonized standards with Obelis.
Sun Protection Factor Determination Guidelines
More insight on the factors determining sun production factor (SPF) of sunscreens as laid down by EU cosmetics regulation 1223/2009/EC.