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Consolidated Version of MDD 93/42/EEC available
After the release of EC-guideline 2007/47/EC in Septembre 2007, the consolidated text of EC-guideline 93/42/EEC are available now and can be downloaded from the EUR-Lex webpage:
RL 93/42/EWG (German)
RL 93/42/EWG (English)
Changes to former text passages are indicated with (M5). Compared with revision M4 following main areas have been subject to changes:
- Changes and enhancement of the Essential Requirements of annex I;
- Uprated calssification of certain devices;
- Intensification of the conformity assessment procedures for class IIa and IIb devices;
- Intensification of the requirements to the clinical evaluation;
- Obligation to label certain medical devices, including plasticizer;
- Obligation to inform about risks related to the reuse of devices intended to be single-used.
Sources:
- Europäische Kommission (EUR-Lex)
- BVMED