The Unique Device Identification (UDI) system was conceived as a means of harmonizing identification of medical devices throughout the distribution chain and at the point of use. UDI is required on labeling for Class II and III devices sold in the US (Class I enforcement begins September 2022), and you are likely aware that it’s coming soon under the EU MDR. Less commonly known is the fact that other countries and regions around the globe are also beginning to require […]» Read more
UPDATED October 23, 2020 With the MDR deadline approaching, many medical device manufacturers do not know for certain whether their Notified Body (NB) will be designated and when! There is no current list of Notified Bodies seeking designation. However, the European Commission has stated that 44 MDR and 11 IVDR applications have been received. That represents a surprising 86% of current MDD NBs and 50% of IVDD NBs. The organizations on the list below account for more than 80% of […]» Read more
If you have worked in European regulatory affairs for some time, it’s hard to wrap your brain around the fact that the United Kingdom is no longer part of the European Union. Moving forward the UK will forge its own path, interacting with its continental neighbors in a manner similar to Norway. Yet the key difference is that Norway has chosen to emulate the EU Medical Device Regulation (2017/745) as national law and require CE Marking. The UK, not so […]» Read more
FDA Part 11 for Medical Device Manufacturers: Are You Complying With These Four Critical Requirements?
The first paragraph of 21 CFR Part 11 seems disarmingly straightforward. It says: “The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.” So simple…or so it seems. But as you are discovering, the “devil is in the details.” The Top Four Part 11 Compliance Requirements for Medical Device Companies […]» Read more