Drug Medical Device Combination

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Combination Products | FDA - U.S. Food and Drug …

https://www.fda.gov/combination-products

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Frequently Asked Questions About Combination …

https://www.fda.gov/combination-products/about-combination-products/frequently-asked-questions-about-combination-products

Under 21 CFR 3.2 (e), a combination product is defined to include: 1. A product comprised of two or more regulated components (i.e., drug/device, …

Combination Products Guidance Documents | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/combination-products-guidance-documents

Guidance Documents: Principles of Premarket Pathways for Combination Products -01/2022. Technical Considerations for Demonstrating Reliability of Emergency …

Drug-Device Combination Products under MDR | BSI …

https://www.bsigroup.com/en-US/medical-devices/Technologies/drug-device-combination-products/

Introduced by the European Commission under the Medical Devices Regulation (MDR), Article 117 requires manufacturers placing drug-device combination products onto the market as an integral device and …

Guideline on the quality requirements for drug …

https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-requirements-drug-device-combinations-first-version_en.pdf

62 of the Regulation (EU) 2017/745 on medical devices (the MDR). These Articles describe the two types 63 of integral drug-device combination products authorised under the …

Medical device combination products: what …

https://qbdgroup.com/en/blog/medical-device-combination-products-regulations-eu/

Regulatory Affairs. September 30, 2021. Follow these steps before launching medical device combination products in the EU, including the application of MDR Article 117 and the EMA Directive. In …

MDR Article 117: Implications for Drug-device …

https://www.celegence.com/mdr-article-117-implication-drug-device-combination-products/

The New System for CE Marking Combination Products – Article 117. The EMA, which oversees the European Union’s pharmaceutical market, has begun rolling out guidance …

An overview of drug-device combination products in the EU

https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/an-overview-of-drug-device-combination-products-in-the-eu/

An overview of drug-device combination products in the EU. For the purpose of this blog post, drug-device combination products are therapeutic and diagnostic products that may combine medicinal …