The 10th round of Transatlantic Trade and Investment Partnership negotiations included discussions on market access, practices, and device identification.
Medical devices and healthcare
European Court of Justice to Clarify Liability for Medical Device
The European Court of Justice, by request of Germany's Federal Supreme Court, will clarify the liability of notified bodies in relation to medical devices.
Final opinion on the Safety of Medical Devices containing DEHP (phthalate)
Scientific Committee on Emerging and Newly Identified Health Risks publish final opinion on safety of medical devices containing DEHP (phthalate).
Revised animal tissue standard could be available by the end of 2015
A revised standard on medical devices utilizing animal tissue could be available by the end of 2015 with new EU regulation 722/2012.
IMDRF proposes QMS Principles for Software as a Medical Device
The new International Medical Device Regulators Forum guidance provides direction on utilizing quality management systems for software as a medical device.
Eu Council agrees on a General Approach for Medical Devices and IVDs Regulations
The Council of the European Union has agreed on a general approach to new medical and in-vitro diagnostic device regulations to be finalized by the end of 2015.
FDA vs. EU compliance under the new Medical Device Regulation
Explaining the difference between EU and FDA compliance under the new EU medical device regulation. Learn more about registration, notified bodies and more.
Aesthetic Products Under New Medical Device Regulation
The EU medical device regulation has created a new category known as 'Aesthetic Devices'. These are defined as devices “without and intended medical purpose”.
EU Regulation on Animal by-products affects Medical Devices & Cosmetics
Read more about how EU regulations 1069/2009 and 142/2001 may affect medical devices and cosmetics products linked to animal by-products.
Basics of In-Vitro Diagnostic Medical Device Classification
In this blog we will try to shed some light on the IVD classification process. IVDs are classified by potential risk to the user and fall into four main groups. Read more about the topic.