The EC's public workshop on the proposed new EU medical device regulations held in February 2013 included talks on scope, requirements, and compliance.
Medical devices and healthcare
Promotion & advertising rules for Medical Devices by EU Directives
Guidelines for advertising and promoting medical devices on the EU market as covered by directive 93/42/EEC. Ensure your product's compliance with Obelis.
Eucomed welcoming medical device proposals with reservations
EU medical technology association expresses its welcome to proposal of new medical device and in-vitro diagnostic regulations within Europe.
New Electronic Labeling for Medical Devices
Newly adopted EC regulation EU 207/2012 will introduce a new electronic labeling requirement for medical devices on the European market.
Ireland EU Presidency, to influence Medical Device Regulations
Ireland's 2013 EU presidency to set increased focus on requirements for notified bodies, medical device manufacturers, and authorized representatives.
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.