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http://meddev.info/_documents/2_1_3_rev_3-12_2009_en.pdf
EUROPEAN COMMISSION DG ENTERPRISE and INDUSTRY Directorate F, Unit F3 “Cosmetics and medical devices” MEDICAL DEVICES: Guidance document - Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative MEDDEV 2. 1/3 rev 3
https://drug-dev.com/device-regulations-the-new-medical-device-regulation-the-applicability-of-article-117-to-medicinal-products/
The MDR has been very clear that “grandfathering” of existing products is no longer permitted, and new certificates need to be issued for all medical devices in class 2 or higher. The case is not so clear cut for medicinal products and their integrated device elements, as such products fall under the medicinal products system.
https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/changes-in-the-medical-devices-regulation-affect-drug-delivery-devices/
Jul 10, 2017 · The Medical Devices Regulation introduces significant changes in approval process under the Medicinal Products Directive. Article 117 of the Medical Devices Regulation (MDR) (Regulation (EU) 2017/745) amends the Directive on medicinal products for human use (MPD) (Directive 2001/83/EC).This will significantly affect pharmaceutical manufacturers supplying drug delivery …
https://www.ebe-biopharma.eu/publication/ebe-reflection-paper-on-medicinal-product-incorporating-a-drug-delivery-device-component-an-industry-perspective-on-the-eu-marketing-application-technical-requirements-regulatory-review-process-an/
Jan 15, 2018 · Within the European Biopharmaceutical Enterprises (EBE), a working group focused on EU specific topics relating to those integral combination products, which are regulated as medicinal products but which contain a drug delivery device component. The EMA Quality Working Party and Biologics Working Party communicated in a recent concept paper(*) their intent to develop a guideline on
https://www.ebe-biopharma.eu/publication/ebe-refection-paper-medicinal-product-incorporating-a-drug-delivery-device-component-an-industry-perspective-on-developing-an-efficient-end-to-end-control-strategy/
Jun 12, 2019 · A cross-industry working group within EBE (European Biopharmaceutical Enterprises) has recently focused on EU specific topics relating to those integral combination products which are regulated as medicinal products but which contain a drug delivery device component. The working group developed a reflection paper which provides an Industry perspective on the development of
https://www.fda.gov/combination-products
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Combination products are therapeutic and diagnostic products that combine ...
https://www.ondrugdelivery.com/ancillary-delivery-devices-undergo-equal-scrutiny-as-standalone-medical-devices/
In the EU, combination products are regulated as either medicinal products or medical devices, depending on which component has the ancillary function. Insulin injector pens and metered dose inhalers, for example, contain a medical device component which serves as the delivery system of the integral drug component – making its role ancillary ...
https://www.ema.europa.eu/en/documents/presentation/presentation-interface-between-medicinal-product-medical-devices-development-update-ema_en.pdf
Medicinal products with integral device component e.g. (pre-filled syringes)to contain Declaration of conformity, CE cert or NB opinion (“MDR Article 117”) [NEW] 16 EMA implementation of the new medical devices legislation EMA’s future role in review of medicinal product and medical
http://www.nsf.org/newsroom_pdf/md_regulatory_pathways_j31.pdf
Regulatory Pathways of Drug-Device and Device-Drug Combination Products in the EU – Journal 31 NSF: Ann Arbor, MI. Key Point Summary: 1. It’s critical to understand the main mode of action of your product as that will determine whether it will be regulated as a medical device or as a medicinal product (drug) in the EU. 2. Once you know what ...
https://www.fdanews.com/ext/resources/files/archives/f/FDL2011.pdf
Drug-delivery products can be regulated in the EU as either medicinal products or medi-cal devices, depending on the exact type of product. For instance, a product shall be regu-lated as a drug if it comprises a device that in-cludes a pharmaceutical product, exclusively in .
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