2026/2660(DEA)
List of class IIb implantable devices exempted from the obligation to perform an assessment of the technical documentation for every device
Basic information
2026/2660(DEA)
DEA - Delegated acts procedure
Supplementing 2012/0266(COD)
Subject
2.10.03 Standardisation, EC/EU standards and trade mark, certification, compliance
3.40.11 Precision engineering, optics, photography, medical
4.20.05 Health legislation and policy
4.60.08 Safety of products and services, product liability
Status
Procedure completed - delegated act enters into force
Key players
-
European Parliament
Committee responsible Rapporteur Appointed SANT
Key events
| Date | Event | Reference | Summary |
|---|---|---|---|
| 20/03/2026 | Non-legislative basic document published | C(2026)01809 | |
| 20/03/2026 | Initial period for examining delegated act 3 month(s) | ||
| 25/03/2026 | Committee referral announced in Parliament | ||
| 11/05/2026 | Delegated act not objected by Council | ||
| 01/07/2026 | Delegated act not objected by Parliament |
Technical information
| Procedure reference | 2026/2660(DEA) |
|---|---|
| Procedure type | DEA - Delegated acts procedure |
| Procedure subtype | Examination of delegated act |
| Amendments and repeals | Supplementing 2012/0266(COD) |
| Stage reached in procedure | Procedure completed - delegated act enters into force |
| Committee dossier |
SANT/10/05463
|
Documentation gateway
-
Document type Reference Date Summary Non-legislative basic document C(2026)01809 20/03/2026 Document attached to the procedure C(2026)3813 01/06/2026
Additional information
| Source | Document | Date |
|---|---|---|
| European Commission | EUR-Lex |