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

Awaiting committee decision

Key players

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

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 Awaiting committee decision
Committee dossier SANT/10/05463

Documentation gateway

  • Document type Reference Date Summary
    Non-legislative basic document C(2026)01809 20/03/2026

Additional information

Source Document Date
European Commission EUR-Lex