Step Aside MDD – There’s a New Sheriff in Town: EU MDR

MDD is no longer in effect in the EU. Starting May 26, 2021 the EU MDR is the law of the land.

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 […]

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Non-Product Software Risk Assessment for Medical Device Manufacturers

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 […]

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FDA 21 CFR Part 11 Compliance 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 […]

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Latest EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) Updates

Following are a series of articles covering key EU MDR and IVDR topics.  Check back often for up to date news on which Notified Bodies have been designated, UDI, the European Commission implementation plan, timelines, and more.   Which EU Notified Bodies Will Be Designated Under the MDR and IVDR? Most recent update: August 19, 2021 We have compiled a list of all Notified Bodies that are currently designated for each Regulation along with links to their scope of services. […]

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