EC publishes revised Blue Guide on implementation of product rules to reflect modernization and harmonization of legislative framework for product marketing.
Medical devices and healthcare
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.
ISO 9001:2015 – What You Need to Know
Find out more about ISO 9001:2015 – why it is coming into effect, what impact it may have for your products, transition periods, and how to prepare for it.
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.
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.