Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 18
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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 1 — Unit 1.2.2 |
| Scope | MD |
| Document part | Article 18 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Conformity assessment, Notified body, Medical device, Manufacturer |
Content
Approved bodies and the conformity assessment procedures for general medical devices 18.—(1) An approved body which is responsible for carrying out a conformity assessmentprocedure in relation to a relevant device shall, when carrying out the procedure— (a) take account of the results of any assessment or verification operations which have beencarried out at an intermediate stage of manufacture of the device; (b) take account of any relevant information relating to the characteristics and performanceof that device; and (c) lay down, by common accord with the manufacturer or his authorised representative, thetime limits for completion of the assessment and verification operations referred to inAnnex II to IV.
(2) Where an approved body takes a decision in accordance withAnnex II, III, V orVI, they shall specify the period of validity of the decision, which initially shall be for a period ofnot more than five years.
(3) Where an approved body and a manufacturer or the manufacturer’s UK responsibleperson have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on applicationfrom and with the agreement of the manufacturer or the manufacturer’s UK responsible person,extend the period of validity of the decision for further periods of up to five years, each such periodcommencing on the expiry of the previous period.
