Ireland's 2013 EU presidency to set increased focus on requirements for notified bodies, medical device manufacturers, and authorized representatives.
News
Regulatory updates on the standard EN 980
More information on the previously missing EU standards EN 980 and EN ISO 15223-1. The Commission's intention was to have EN ISO 15225-1 replace EN 980.
How and whether to Audit Authorized Representatives?
The European Association of Notified Bodies for Medical Devices have published a paper questioning the auditing process for Authorized Representatives.
Impact on the Authorized Representative by NEW medical device proposals
Learn more with Obelis about the impact the new medical and in-vitro device regulation proposals may have for Authorized Representatives within the EU.
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 Agency for Medical Device Registration in France
In April 2012, the National Agency for the Safety of Medicines and Health Products will replace current medical device regulatory agency, Afssaps, in France.
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.