Module 12 Presentations

29/01/2024

Number of legislations

Active Implantable Medical Device Directive 90/385/EEC

Medical Device Regulation 2017/745

Medical Device Directive 93/42/EC

In Vitro Medical Device Regulation 2017/746

In-Vitro Medical Device Directive 98/79/EC

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Directive vs Regulation

Directive

Regulation

Gives directions to member states

Legally entering in force in all member state

Each National authority must create or adapt their legislation

No need to adapt National authorities legislation

Member state can decide freely to transpose the directive into National law

All that is written is applied by a set date

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