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https://www.mddionline.com/whats-latest-drug-delivery-devices
May 22, 2019 · The new regulation in Europe, Medical Device Regulations (2017/745), stipulates that marketing authorization applications for medicines with an integral medical device must include the results of the device’s assessment of conformity by a notified body. ... MD+DI: How would the need for sterile drug delivery and/or terminal sterilization ...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-product-classification-issues
If the classification of a product as a drug, device, biological product, or combination product is unclear or in dispute, a sponsor can submit an RFD to OCP in accordance with Part 3 of Title 21 ...
https://www.fda.gov/combination-products/about-combination-products/frequently-asked-questions-about-combination-products
A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug ...
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 devices in combination ...
https://www.meddeviceonline.com/doc/a-primer-on-investigational-drug-delivery-device-regulatory-requirements-0001
Nov 16, 2015 · The device part of a drug/ delivery system submissions needs to comply to the device requirements for investigational devices – with a few other common sense considerations. Combination drug/device delivery products are becoming the standard of care in many therapeutic areas.
https://drug-dev.com/device-regulations-the-new-medical-device-regulation-the-applicability-of-article-117-to-medicinal-products/
Device elements of medicinal products are likely to automatically increase the risk classification due to the presence of the drug product. It should also be considered that even a device element that would be classed as a class I medical device – and thus subject to self-certification – would still need a Notified Body review and opinion.
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 ...File Size: 681KB
https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-requirements-drug-device-combinations_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 medicines ’ framework: 64 1. Devices that when placed on the market or put into service incorporate , as an integral part, a
https://www.ema.europa.eu/en/quality-requirements-drug-device-combinations
Guidance is provided on dossier requirements for drug-device combinations (DDCs) in the context of a regulatory submission (marketing authorisation application and post-authorisation application). The types of DDCs within the scope of this guideline are medical devices that are integral to the medicinal product, co-packaged with the medicinal product or referenced in the medicinal product ...
https://www.ondrugdelivery.com/magazines/pulmonary-nasal-delivery-85/
Mary Hutchens gives an overview of some of the changes wrought by last year’s introduction of the new EU Medical Device Regulation, with a specific view to its effect on inhalation devices and inhaled medical products. ... MEETING FUTURE NEEDS FOR RESPIRATORY DRUG DELIVERY DEVELOPMENT .
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