Scientific Committee on Emerging and Newly Identified Health Risks publish final opinion on safety of medical devices containing DEHP (phthalate).
Medical devices and healthcare auto
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.
Is English Sufficient for my Instructions for Use?
Ensuring all relevant product information is communicated clearly is an extremely important part of the compliance and market entry process for medical devices. As a general rule of thumb, any information pertaining to the product and its intended use should be outlined in at least the native language of every country on the European Market it is being released to.
Can I use a CE Mark if I don’t sell in the EU?
In this blog, we will explore CE marking’s role, or lack thereof, in allowing a product access to the global market.