NAVIGATING THE EU MEDICAL DEVICE REGULATION | EVENT 2: FOR COMPANIES WITH KNOWLEDGE OF THE EUMDR
You have two, FREE, virtual events to choose from focused on Navigating the EU MDR.
This is Event 2 registration, a detailed EU MDR presentation specifically for companies with knowledge of the EU.
- What does EU MDR mean for your bottom line?
- Learn how to navigate the EUMDR from:
Nina Brkuljan, Senior Commercial Specialist, U.S. Mission to the European Union, and
Maria Duguine, PhD Chemistry, Consultant, RQMIS(EU/UK/US regulatory consulting firm)
- Understand the forces behind the regulation and the current implementation strategy.
- Learn the certification process, time commitment and resources needed to be successful.
Who Should Attend?
- Medical device producers including (stents, catheters)
- Medication producers that use certain applicators
- Certain cosmetics and food supplement producers
Gain knowledge about MDR, how it applies to your products, and more!
What is EU MDR?
The Medical Device Regulation (MDR) changed the European legal framework for medical devices and introduced new responsibilities for the European Medicines Agency (EMA) and for national authorities in the assessment of certain categories of products.
The MDR introduces new or revised responsibilities for EMA for:
- Medicines with an integral device, such as pre-filled syringes and pens, and pre-filled inhalers;
- Medical devices containing an ancillary medicinal substance to support the proper functioning of the device, for example drug-eluting stents, bone cement containing an antibiotic, catheters coated with an antibiotic agent and condoms coated with spermicides;
- Medical devices made from substances that are absorbed by the human body to achieve their intended purpose; and
- Borderline products for which there is uncertainty over which regulatory framework applies. Common borderlines are between medicinal products, medical devices, cosmetics, biocidal products, herbal medicines and food supplements (European Medicines Agency, 2022)
Selling or planning to sell to the EU – you won’t want to miss this!