1. Update on the new EU In Vitro Diagnostic Medical Device Regulation: Seven Key Changes
In this article we are look at the seven key changes to the In Vitro Diagnostic Medical Device regulations. In vitro diagnostic medical devices (IVDs) cover a wide range of products that can be used for diagnosis, therapeutic drug monitoring, disease screening, assessment of medical interventions and population screening. Manufacturers of IVDs need to comply with the in vitro medical device regulations directive 98/79/EC in order to place their products on the market in the EU. Read More Here2. CE Marking an IVD Medical Device
Our second most popular medical device news article of the year was another IVD related story. We started by asking: Does the product meet the definition of an in vitro diagnostic medical device? The first step is to determine if your product meets the definition of a medical device under the EU In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC definition: ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information Read More Here.3. CE Marking A Medical Device Which Incorporates A Medicine
We are consistently asked about CE marking a medical device. Our team of medical device experts has written a brief overview for how a company can secure CE marking for a medical device that incorporates a medicine. Read More Here.4. Medical Device Post-Market Obligations – a European Perspective: Part 1 – Post-Market Surveillance
Stories 4&5 were both written in 2015 but continue to attract attention. Our article asked: Under the European IVD and medical device directives, once a Manufacturer has CE marked their device and placed it on the market they still have to meet certain obligations. Implementation of a system for post-market surveillance is a requirement for all classes of IVDs and medical devices, but what is post market surveillance, and what does this mean in practice? Read More Here.5. EU Medical Device Vigilance Reporting: Part 2 – Frequently Asked Questions
In part 1 of this series we gave you a quick overview of the medical device vigilance reporting requirements for IVD and medical device manufacturers. In this article, we are going to delve a bit deeper and answer some questions about vigilance reporting that we are regularly asked by clients. Read More Here.
