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Regulating medical devices in the UK - GOV.UK
- https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
- CE markingWe will continue to accept CE marked devices on the Great Britain market until …EU Notified BodiesAny mandatory third-party conformity assessment for the CE marking m… See more
Council Directive 93/42/EEC of 14 June 1993 concerning medical …
- https://www.legislation.gov.uk/eudr/1993/42/2020-12-31
- Whereas certain medical devices are intended to administer medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on …
MEDICAL DEVICES Guidance document …
- https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native
- Conformity assessment is the method by which a manufacturer demonstrates that their devices comply with the requirements of Directive 93/42/EEC. The classification of the …
B COUNCIL DIRECTIVE 93/42/EEC of 14 June …
- https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
- COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the …
Mandatory Language Requirements for Medical Devices
- https://www.johner-institut.de/blog/wp-content/uploads/2015/10/020205_Mandatory_Language.pdf
- Depending on the Medical Devices Directive (93/42/EEC)- MDD - the member states of the European Economic Area, EEA, can require their own language. All of them have …
Medical Device Directive (MDD), Directive 93/42/EEC - Lexparency
- https://lexparency.org/eu/31993L0042/
- Medical Device Directive – MDD. Recitals. Article 1 — Definitions, scope. Article 2 — Placing on the market and putting into service. Article 3 — Essential …
Medical Devices Directive 93/42/EEC is due …
- https://www.cti-cem.com/blog/medical-devices-directive-93-42-eec/
- Equipment which (in the UK at least) is not considered to fall within the scope of the Medical Devices Directive 93/42/EEC includes: Toothbrushes Baby nappies …
Mandatory Languages Requirements for Medical Devices
- https://www.team-nb.org/wp-content/uploads/2015/05/documents2012andolders/MDEG_-_2008-12_-_II-6.3._Mandatory_Languages_Requirements_for_Medical_Devices_update_Sept.08.pdf
- MDEG - 2008-12 - II-6.3. Mandatory Languages Requirements for Medical Devices update Sept.08 ...
Language Translation Requirements for IVD's on the EU Market
- https://elsmar.com/elsmarqualityforum/threads/language-translation-requirements-for-ivds-on-the-eu-market.63375/
- Please refer our existing posts "Official Language in EU required for Medical Device Labeling" and below links TEAM MDEG's Mandatory Languages Requirements …
Medical Device Regulation: Requirements for Dental
- https://pubmed.ncbi.nlm.nih.gov/33722134/
- Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices. A custom-made device (CMD) is a medical device …
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