New information on the progress and delays to new proposed EU medical device legislation from Europe's leading regulatory and compliance experts.
Medical devices and healthcare
Irish Authorities restructure
From July 2014, the national Irish medical and cosmetics regulator, Health Products Regulatory Authority, will become known as the Irish Medicines Board.
Italy Decree on online registration of IVDs!
Italy enacts decree requiring in-vitro diagnostics device manufacturers with devices on the Italian market to register products with health ministry database.
Legal Challenges at time of Non-Renewal of a CE certificate
More information on the legal challenges and difficulties that may result from non-renewal of CE certification for products place on the European market.
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.
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.
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.
TTIP and SMEs: what potential?
Learn more about the potential benefits the Transatlantic Trade and Investment Partnership may have for small-to-medium-sized enterprizes across the EU and US.