Health~Holland Webinar | How does the MDR affect you?

If your company places medical devices on the EU market, this is an important session for you. The MDR addresses Economic Operators (EOs), which are the Manufacturer, Authorized Representative, Importer and Distributor (MAID). The MDR doesn’t only requires manufacturers to have control over their distribution chain and to monitor devices once they are introduced in the market. But also requires the importer and distributor to follow the devices and provide PMS data to the manufacturer. What is your role and what do you need to comply with?

During this webinar, Emergo will elaborate on the requirements for EOs and what their role within the PMS system is. What do you need to take into account as a Dutch manufacturer/importer or distributor of medical devices? Participation is free.

What is it about?

The MDR requires manufacturers to have control over their distribution chain and require distributors and importers to co-operate with manufacturers and/or Authorized Representatives. All EOs make part of the manufacturers  PMS system.  What is your role, or do you have multiple roles? And what obligations come with that role? Emergo will tell you all about these new requirements under MDR. During a Q&A you can gain additional in-depth knowledge and advice.

About the speaker: Annette van Raamsdonk (Emergo) 

Van Raamsdonk gained significant experience with a broad variety of medical devices working at TÜV Rheinland and serving as Inspector of Medical Technology at the Dutch Health and Youth Care Inspectorate (IGJ). She represented the IGJ within the European Competent Authorities working group for Compliance and Enforcement and is currently main contact person towards European Competent Authorities. Areas of expertise include European medical device legislation, borderline issues, classification of medical devices and Competent Authority supervision. Over the past years, van Raamsdonk has been intensively involved in the implementation of the MDR and IVDR and contributed to European guidance documents (among others PMS guidance and Annex XVI Common Specification) on the MDR. She also participates in several EU working groups of the EC and national working groups.

After this webinar, you will know…

  • What your role under the MDR is
  • What your obligations are under the MDR as a Dutch manufacturer/importer/distributor of medical devices
  • Why and how you need to co-operate with other EOs

When and where?

This webinar will take place on May 12 from 09.00 to 11.00 AM. We will host it on Remo, a user-friendly digital meeting space.

Register today!

Do you want to know how your company can meet the requirements? Looking for expert advice on PMS and PMCF? Join our webinar on the MDR: sign up here for FREE.

Source: TFHC

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