White Paper:
Navigating the European Union’s (EU) Drug Device Combination Product Regulatory Changes
The European therapeutics market has been working to manage the upheaval caused by Brexit and is now working its way through yet another challenge: the medical devices regulation (MDR) changes that will soon go into effect and have significant impact on the regulation of combination products.
Regulation (EU) 2017/745 was enacted into law on May 25, 2017, replacing the EU’s Medical Device Directive (93/42EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). Per Article 117 of the new regulation, medicinal products with an integral medical device are subject to new requirements. Although a transition period was established, manufacturers and developers submitting drug–device combination (DDC) products for market approval on or after May 26, 2020, must comply with the new regulations.
With this deadline looming less than a year from now, what do these new regulations mean for combination drug manufacturers?
Download the Whitepaper
Complete the form below to download your copy!
You might also be interested in…
eBook: Key Considerations in Gene Therapy Manufacturing for Commercialization
eBook: Key Considerations in Gene Therapy Manufacturing for Commercialization “The regulatory landscape for gene therapies is as transforming as the curative nature of a transgene. In 2012, we saw the introduction of the Breakthrough Therapy Designation. Just when you...
White Paper: 4 Things You Need to Know About Combination Drug Compliance
White Paper: 4 Things You Need to Know About Combination Drug ComplianceCombination products are a fascinating area of the pharmaceutical industry and present great future promise. The segment is projected to reach $115 billion in global sales by the end of 2019. It...
White Paper: 4 Steps for Managing Biopharmaceutical Projects
White Paper: White Paper: 4 Steps for Managing Biopharmaceutical Projects By Tracy TreDenick, Head of Regulatory and Quality, and Senior Consultant, and Julie Spyrison Associate Director, Regulatory Operations at BioTechLogic, Inc. The global biopharmaceutical market...