On this 2 part episode, Erik Vollebregt will open our eyes about the EU MDR 2017/745 and EU IVDR 2017/746.

On his blog, MedicalDeviceslegal.com, he share openly his opinion about Medical Device Regulations. As he is a lawyer at AXON Lawyer firm, he has this ability to tell us stories like if this was a speach done in a justice court.

I asked him all the questions about EU MDR and IVDR and also about Brexit which we will see more on Part 2.

Erik specialises in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.

He actively contributes to law and policy development at national and EU level via membership of specialized committees at branch associations and the European Commission. Erik also works as arbitrator in medical devices related disputes and is regularly retained as expert witness in foreign litigation.

Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Chambers Europe 2017 about Erik:

He is known for his specialism in regulatory work, which covers medical technology, devices and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Erik’s Linkedin Profile: https://www.linkedin.com/in/erikvollebregt

https://www.youtube.com/embed/xk_Rm9s2V_A?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi