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.
Medical devices and healthcare
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.
Progress on upcoming regulations on Medical Devices
EU Council report shows progress on proposed new medical device and in-vitro diagnostic device regulations to replace previous European directives.
Transatlantic Trade and Investment Partnership: Steps towards faster access to Medical Devices
Recent reports suggest that the Transatlantic Trade and Investment Partnership may likely lead to easier circulation of medical devices between the EU and USA.
New EU Rapporteur for the Medical Devices Revision Package
In September 2014, the EU Parliament appointed UK Labor Party member Glenis Wilmott as new rapporteur in ongoing medical device legislation revision.
New version of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices
New version of EU Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices published in September 2014.
Formula Verification Service
European regulatory and compliance experts Obelis announce new formula verification service for manufacturers starting the EU compliance process.