Regulation
Regulation is, under Article 288 TFEU, the most binding type of EU legal act. It applies directly in all EU Member States without national implementing legislation.
Distinctions between EU legal acts:
- Regulation: applies directly, no implementing act needed - e.g. MDR, PPE Reg., REACH
- Directive: binding objective, but Member States determine the means of implementation - e.g. former MDD 93/42/EEC, PPE Directive 89/686/EEC
- Decision: binding only on addressees
- Recommendation/Opinion: not binding
For medical devices and PPE, the shift from Directives to Regulations since 2016-2021:
- MDR (EU) 2017/745: Medical Device Regulation (since 2021)
- IVDR (EU) 2017/746: In vitro Diagnostic Regulation
- PPE Reg. (EU) 2016/425: PPE Regulation (since 2019)
- REACH (EC) 1907/2006: Chemicals Regulation
The shift from Directives to Regulations aims to ensure more uniform application across all Member States and minimise national interpretive differences.
Frequently asked questions
What is the difference between an EU Regulation and an EU Directive?
An EU Regulation applies directly in all Member States without national transposition (e.g. MDR, PPE Reg.). An EU Directive sets binding objectives but Member States must transpose it into national law. The MDD (93/42/EEC) was a Directive; the MDR is a Regulation.
Why were Directives replaced by Regulations?
Directives lead to national differences in implementation. Regulations apply uniformly across the EU directly, reducing competitive distortions and creating a more consistent regulatory level.
Does an EU Regulation also apply in non-EU countries?
No. EU Regulations apply only within the EEA. However, manufacturers outside the EU wishing to export to the EEA must comply with EU requirements and, for example, designate an EU Authorised Representative.