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R&Q Webinar: EU MDR for Combination Products
April 23 @ 1:00 pm - 2:00 pm
Join BioOhio member R&Q on Tuesday, April 23 at 1pm ET for this month’s free webinar: EU MDR for Combination Products. Fresh off of their recent Advanced EU MDR and CER Workshops in Minneapolis and Boston, R&Q’s Director of Regulatory Affairs Nancy Morrison will be presenting.
The rules have changed with Article 117 and more companies will require notified body involvement. This is the first time devices integral to a drug product will require notified body assessment. Although the requirements are a subset of the full regulation, it will require compliance with the General Safety and Performance Requirements – which we’ll explore. We’ll also explore guidance issued by European Medicines Agency on Article 117 and how they are interpreting what is an integral device with the medicinal substance.