► Webpage: [ Ссылка ]

The definition of a Significant change is instrumental to have the right strategy for your devices. This is why I have invited Erik Vollebregt to help us understand the different situations where you are executing a Significant change to your device.

Because if you are MDD are benefit from the transition period, then a significant change will make you fall immediately under MDR. If you are not ready for that this is a catastrophe.

So I hope this episode will help you avoid some mistakes.

In this episode, we also talk about the MDCG guidance and after we recorded it, the MDCG group issued the guidance. I put them on the link below. Also, check Erik's blog to know more about this guidance.

-----------------------------------------------------------------------------------------------------------------------------
► Who is Erik Vollebregt

Erik specializes 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 the 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 the national and EU levels via membership of specialized committees at branch associations and the European Commission.

Erik also works as an arbitrator in medical devices related disputes and is regularly retained as an 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: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for 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.”

-----------------------------------------------------------------------------------------------------------------------------
► Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses...

--------------------------------------------------------------------------------------------
► Links from the Video

■ Erik Vollebregt LinkedIn Profile: [ Ссылка ]
■ Axon Lawyers website: [ Ссылка ]
■ Erik Vollebregt Blog on Significant Change: [ Ссылка ]
■ MDCG 2020-3 Guidance significant change: [ Ссылка ]
■ CAMD FAQ question - MDR Transitional provision: [ Ссылка ]
■ LNE GMED guidance: [ Ссылка ]
■ Medtech Europe - Joint Industry Position on Significant Changes according to MDR Article 120(3): [ Ссылка ]

-------------------------------------------------------------------------------------------
► Social Media to follow

■ Monir El Azzouzi Linkedin: [ Ссылка ]
■ Twitter: [ Ссылка ]
■ Pinterest: [ Ссылка ]
■ Instagram: [ Ссылка ]

------------------------------------------------------------------------------------------
#medtech #medicaldevice #compliance

свернуть