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Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- Role of EMA. EMA is responsible for evaluating the quality, safety and efficacy of marketing authorisation applications assessed through the centralised procedure, including the safety and performance of a medical device in relation to its use with a …
Medical Device Regulation comes into application
- https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
- The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal …
Glossary | European Medicines Agency
- https://www.ema.europa.eu/en/about-us/about-website/glossary
- EMA’s medical terms simplifier gives plain-language descriptions of medical terms commonly used in information about medicines: EMA medical terms simplifier. The …
MDR - Article 2 - Definitions - Medical Device Regulation
- https://www.medical-device-regulation.eu/2019/07/10/mdr-article-2-definitions/
- Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘medical device’ means any instrument, apparatus, appliance, …
QWP-BWP Guideline on medicinal products used …
- https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-documentation-medicinal-products-when-used-medical-device-first-version_en.pdf
- the medical device is packed together with the medicinal product (hereafter called co-packaged), or • Medicinal products, where the product information refers to a specific …
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
- 69 Typically, these devices have measuring, metering or delivery function s. 70 . Examples of medical devices in integral DDCs are: 71 Devices for delivery to site of action e.g. the …
Medicinal product | European Medicines Agency
- https://www.ema.europa.eu/en/glossary/medicinal-product
- Medicinal product. A substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by …
Advanced therapy medicinal products: …
- https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview
- Table of contents. Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer …
How to Determine if Your Product is a Medical Device | FDA
- https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
- The following steps may be helpful when trying to determine if a product is regulated by the FDA as a medical device. Step 1: Determine if your product meets the …
Ancillary medicinal substance | European Medicines …
- https://www.ema.europa.eu/en/glossary/ancillary-medicinal-substance
- Ancillary medicinal substance. A medicine that is incorporated within a medical device where the main mode of action is due to the device. More information can be found under ' …
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