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Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active …
Quality documentation for medicinal products when used …
- https://www.ema.europa.eu/en/quality-documentation-medicinal-products-when-used-medical-device-scientific-guideline
- Document history. This guideline describes the information that should be presented in the quality part of a marketing authorisation dossier for a medicinal …
Medical Device Regulation comes into application
- https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
- Medical Device Regulation comes into application. Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021. The …
First guidance on new rules for certain medical devices
- https://www.ema.europa.eu/en/news/first-guidance-new-rules-certain-medical-devices
- EMA has published today the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical …
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 …
Questions & Answers for applicants, marketing …
- https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf
- • Medical devices that form an integral product with a medicinal product, • Medicinal products that include a medical device in the secondary packaging of the marketed …
Guidance - Public Health
- https://health.ec.europa.eu/medical-devices-new-regulations/guidance_en
- The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. These are legally non …
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
- 112 With respect to ATMPs, this guideline applies only to devices that are considered part of the container 113 closure system, or medical devices that are co-packaged or …
Quality guidelines | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/quality-guidelines
- The European Medicines Agency's scientific guidelines on the quality of human medicines help applicants prepare marketing authorisation applications. Guidelines …
MEDICAL DEVICES Guidance document …
- https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native
- The classification of medical devices is a ‘risk based’ system based on the vulnerability of the human body taking account of the potential risks associated with the devices. This …
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