Weighing in at 157 pages and 85,000 words, the new European IVD regulation requires serious concentration for regulatory professionals. We’ve made this daunting task a little easier by adding a fully linked, easy-to-navigate Table of Contents to the IVDR. Just download the PDF and save it to your desktop for quick reference.
Inside the EU IVDR (2017/746), you’ll find quick links to every Chapter, Article and Annex. If you are new to IVD regulation in Europe (or even if you are not), you may want to consider our three-day immersive training class on the IVDR changes.… » Read more
The next 12 months are sure to be a wild ride for medical device RA/QA professionals. There’s a lot going on in the world of regulatory compliance and there is little doubt that your workload is about to increase – you may have seen it happening already. Here’s what we are hearing from our clients about issues they expect will consume more of their precious time this year.
1 – Internal audits and gap assessments
The new European medical device and in vitro diagnostic regulations (EU MDR and EU IVDR, respectively) will certainly demand more attention from regulatory professionals in 2019.… » Read more
Download a comprehensive list of MDSAP FAQs and responses here
Audit reports lay bare the good, the bad, and the ugly about a company’s current state of regulatory compliance. Questions have been raised about how Medical Device Single Audit Program (MDSAP) outcomes are shared among regulatory authorities.
In the good ol’ days (circa 2017), if the US FDA did an inspection report, any dirty laundry or proprietary information contained in that report usually stayed in an FDA filing cabinet (assuming you were not issued a warning letter).… » Read more
Compliance with European regulations has become progressively more complex, especially with the recent publication of the EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746). With the new regulations, European regulators want to make sure companies always have a qualified regulatory expert on staff or at their disposal to ensure the company is meeting EU requirements.
You may have heard about a new role called the Person Responsible for Regulatory Compliance as defined in the new EU MDR and IVDR. Article 15 of the European MDR and IVDR mandate the appointment of this person.… » Read more