The European Union’s Medical Device Regulation will lead to major changes for companies and organizations active in the field of medical devices. In May, Health~Holland and Task Force Health Care organised a webinar to help them find out how the MDR will impact their activities.
Participants representing more than 25 companies joined the session. Since the Medical Device Regulation comes with complicated challenges, they had the opportunity to send in questions beforehand.
Intended use
TFHC’s Steven Jonis hosted this webinar. He was accompanied by two specialists from Emergo, a company that provides quality and regulatory compliance consulting to medical device companies.
Regulatory Affairs Manager Annette Raamsdonk and Sales Executive Robert Teng shared their expertise by answering participants’ questions. In addition, Annette gave an in-depth presentation on the implications and meaning of the new Medical Device Regulation. Topics included the intended use of a medical device and other important definitions vendors should take into account.
Deadline delayed
Different timelines for the future were set out, taking into account the postponement of MDR. Originally, it was to be implemented by the end of May 2020 for all manufacturers of medical devices. Because of COVID-19, the deadline has been delayed by one year for manufacturers of Class I Medical Devices.
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