More information on the legal challenges and difficulties that may result from non-renewal of CE certification for products place on the European market.
Medical devices and healthcare auto
New version of the Blue Guide 2014. What is new?
EC publishes revised Blue Guide on implementation of product rules to reflect modernization and harmonization of legislative framework for product marketing.
New IEC 60601-1-2: 4th Edition for Medical Electrical Equipment
International Electrotechnical Commission introduce 4th edition of IEC 6061-1-2:2004 to include technical revisions on risk analysis and immunity requirements.
More Supervision on Notified Bodies by NEW 920/2013 Regulation
New EU implementing regulation 920/2013 to set more stringent requirements for the designation and supervision of Notified Bodies within Europe.
Obelis officially welcomes NEW Proposals of European Medical Device Legislation
EU regulatory and compliance experts Obelis welcome proposal of new medical and in-vitro diagnostic device legislation for Europe.
Public workshop by EC on NEW medical device regulations
The EC's public workshop on the proposed new EU medical device regulations held in February 2013 included talks on scope, requirements, and compliance.
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.