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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 …
Medical Devices | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/Medical-Devices
- Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in …
Living wills and advance directives for medical decisions
- https://www.mayoclinic.org/healthy-lifestyle/consumer-health/in-depth/living-wills/art-20046303
- Power of attorney. A medical or health care power of attorney is a type of advance directive …
B COUNCIL DIRECTIVE 93/42/EEC of 14 June …
- https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
- medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; …
Machinery Directive: What Applys to Medical Devices?
- https://www.johner-institute.com/articles/product-development/and-more/the-machinery-directive-which-parts-apply-to-medical-devices/
- If your medical device might be machinery as defined by the Machinery Directive, follow these five steps to demonstrate conformity: a) Step 1: check whether your device is …
Medical Device Directive (MDD)
- https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf
- Medical Device Directive (MDD) Medical Device Directive (MDD) 93/42/EEC as modified by 2007/47/EC Objectives of “New Approach” Adopted by all Member States Efficient …
EUR-Lex - 31993L0042 - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042
- Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on …
Council Directive 93/42/EEC of 14 June 1993 concerning …
- https://www.legislation.gov.uk/eudr/1993/42/2020-12-31
- 1.This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their …
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