Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 16 (11)
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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 | |
| Reference Details | |
|---|---|
| Module | Module 6 — Unit 6.1.2 |
| Scope | MD |
| Document part | Article 16
(11) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Trial end, Close-out visit, Clinical investigation, Manufacturer, Medical device |
Content
Procedures for general medical devices for clinical investigations 16.— […] (11) The manufacturer, or their single authorised representative, shall— (a)notify the Secretary of State of the end of the clinical investigation; and (b)provide justification where premature termination has resulted
