Welcome to my last MD Regulatory Digest! As you probably noticed, there is only 1 year left until the Date of Application of the MDR. With this anniversary, my series[…]

Welcome back to my 8th MD Regulatory Digest! This week I decided to focus on the PMS & Vigilance. This topic is part of the early obligations that any manufacturer[…]

Welcome back to my 7th MD Regulatory Digest! This week I made a focus on 3 terms defined in the Article 2 of the MDR: ‘making available on the market’,[…]

Welcome back to my 6th MD Regulatory Digest! This week I decided to focus on the UDI System, and more specifically on the difference between UDI and Basic UDI-DI. This[…]

Welcome back to my 5th MD Regulatory Digest! This week my Digest is about new economic operators, focused on importer, distributor and authorized representative. I hope you enjoy it! Download[…]

Welcome back to my 4th MD Regulatory Digest! One of the 1st points to consider for any MD manufacturer or distributor is the scope of the MDR, which is wider[…]

Welcome back to my MD Regulatory Digest! As I mentioned in my 1st digest, the Regulation (EU) 2017/745 brings a lot of changes. Naturally, the manufacturer is an economic operator that[…]

Welcome back to my MD Regulatory Digest! This week, I made a focus on the transition timeline of the Regulation (UE) 2017/745. Of course, I only selected most important dates[…]

Welcome to the MD Regulatory Digest! Every 2 weeks, I will share with you an overview of the latest news in the Medical Device Industry as well as a focus[…]