Document:GBR The Medical Devices Regulations 2002 11-Feb-2021
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| Document information | |
|---|---|
| Reference | GBR The Medical Devices Regulations 2002 11-Feb-2021 |
| Validity area | GBR |
| Scope(s) | MD |
| Document name | The Medical Devices Regulations 2002 |
| Version / Revision | 11-Feb-2021 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | The Medical Devices Regulations 2002 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 18 | MD | Article 18 | EN | Approved bodies and the conformity assessment procedures for general medical devices 18.â(1) An approved body which is responsible for carrying out a conformity assessmentprocedure in relation to a ... |
| Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 in vitro diagnostic medical device | MD | Article 2
in vitro diagnostic medical device || EN || âin vitro diagnostic medical deviceâ means a medical device whichâ (a) is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,equipment or system, whether used alone ... | ||
| Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 medical device | MD | Article 2
medical device || EN || âmedical deviceâ means any instrument, apparatus, appliance, software, material or otherarticle, whether used alone or in combination, together with any accessories, including thesoftware intended by ... | ||
| Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 16 (1) - (3) | MD | Article 16
(1) - (3) || EN || Procedures for general medical devices for clinical investigationsN.I. 16.â(1) Subject to paragraph (2), no person shall supply a relevant device (if that supply is also a making available of the ... | ||
| Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 16 (11) | MD | Article 16
(11) || EN || Procedures for general medical devices for clinical investigations 16.â [âŚ] (11) The manufacturer, or their single authorised representative, shallâ (a)notify the Secretary of State of the end of the ... |
