EU MDR

Part 2: Vigilance and Incident Reporting In the second post of our Post Market Surveillance series we’re going to dive into incident reporting and vigilance.  This section of MDR deals with how your firm [...]

Post Market Surveillance in MDR There are only a handful of explicit things that you HAVE to do under MDR for PMS, however there are a lot more things you SHOULD be doing to [...]

MDR Date Of Application Is Approaching Introduction The May 2020 deadline outline in Reg 2017/745 is a cutoff for new filings under MDD, the previous regulation. If your product is [...]

Periodic Safety Update Reports:  Why You Might Need One Did you know that the Literature Searches you submit for your CE Marking Clinical Evaluation Report might have to be re-run annually? [...]

Cost Savings of Literature Searches in Your CER Introduction We recently had a client that wanted to weigh the option of outsourcing their entire CER project overseas to more attractively [...]

Medical Device Regulations – Links You Should Be Aware Of Overview These are the most important regulations to be aware of governing Medical Devices in the European Union. If you [...]

CE Marking Process in the European Union Introduction This article will detail the various steps you will need to take for an entire CE Certification cycle for your product.   [...]

The Literature Review: Key Component to Successfully Navigating the MDR A New Emphasis On Research It’s obvious that the impending European Commission’s implementation of the [...]