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.
Medical devices and healthcare
Can I Piggyback on my OEMs CE Certificate?
In many ways, a CE Certificate is a passport to the European Market for any medical device. It provides definitive proof that manufacturers and their products adhere to all European compliance regulations and that all standards have been met at each stage of the production process. The certificate itself ensures only the highest quality, safest products reach the EU marketplace.
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.
What are the New Approach Directives?
The New Approach Directives are a series of legislative requirements that ensure product safety within the EU market across a range of products and devices.
New list of harmonized standards for medical devices
In January 2015, the EU Commission published a new list of standards for medical, in-vitro, and implantable devices on the EU market.
Formula Verification Service
European regulatory and compliance experts Obelis announce new formula verification service for manufacturers starting the EU compliance process.
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.