Wednesday, 15. September 2021 | 10:50 - 11:00
Hall 2: Innovation Symposium
How can you adapt to the changes in MDR?
In this presentation you will hear about the preparation of a Transition Plan and you will be provided with the 12 major steps to be ready for new MDR regulations.
Medtech companies are facing major compliance challenges. As of May 26, 2021 new Medical Devices Regulation goes into effect and previous directives cease to apply. European Union expects full adherence across all its member states. Find out what this means for your company.
The importance of medical devices in the health systems across the world is rapidly growing. European Union, with its aging population prone to greater health risks, is seeking to further regulate the MedTech industry with a focus on patients’ safety. New rules contained in the Medical Devices Regulation (MDR) require increased vigilance in preventing medical device malfunctions and adverse events. In general terms, the emphasis is on product lifecycle – not merely getting it to the market. This means, obtaining approval is not enough. Manufacturers face the effort of retaining it as well.
Please find more information here.