Authorized representative. Importer. Distributor. Person Responsible for Regulatory Compliance. The new European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) certainly keep regulatory professionals on their toes. The duties associated with these four roles are outlined in Articles 11, 13, 14, and 15 of both regulations, respectively. However, they can be somewhat confusing because there is significant overlap in what some of these so-called “economic operators” do. In this article, we will give you a rundown on what […]» Read more
Step aside, MDD. There’s a new sheriff in town (metaphorically, that is). Four long years after it was first revealed to the world in 2017, the European Medical Device Regulation (MDR 2017/745) rode into town to take over as the new enforcer of all things medical device on May 26, 2021. Going forward, the Medical Devices Directive (93/42/EEC) is no longer the pathway to CE Marking and all manufacturers are expected to comply with the MDR. Now that MDD has […]» Read more
This is the first article of a three-part series on non-product software risk assessment, validation and testing. Download the entire series in one convenient PDF. Part 1: This article Part 2: Non-Product Software (NPS) Validation for Medical Device Manufacturers Part 3: Writing NPS Protocols and Testing for Medical Device Manufacturers Here’s a relationship tip. If one day your spouse or partner asks you what you did today, never reply by saying that you were working on a master validation plan […]» 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