Other related policies

In addition to the Medical Devices Directives, outlined below is a non-exhaustive list of legislation and non-legislative policies that can have an impact on the medical devices sector.

1. New legislative framework for the marketing of products

2. Pharmaceutical legislation

3. REACH

4. Chemicals legislation

5. Environmental legislation

• Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS)
• Directive on Waste electrical and electronic equipment (WEEE)
• Directive on energy-using products (EuP)
• Ecolabel Regulation
• EMAS Regulation
• Waste Directive
• Biocides Directive

6. Energy legislation

• Energy labelling Directive

7. Machinery Directive

• This interpretative document(23 KB) explains the relation between the medical devices legislation and the Machinery Directive.

8. Personal Protective Equipment

• This interpretative document(32 KB) explains the relation between the medical devices legislation and the Personal Protective Equipment Directive.

9. Directive on Measuring Instruments

10. Directive on human tissues and cells

11. Public procurement

12. Late payment

13. Research: get support
SM-BIO Power and Seventh research Framework Porgram (FP7)

Besides the policies that have been cast into legislation, there are non-legislative policies that might also cover the medical devices sector.

Examples:

New Approach Standardisation in the Internal Market, as European Standardisation is a useful tool which supports the Medical Devices legislative framework.

Patient safety, a policy led by DG Health and Consumer, has disseminated best practices across Member States which partly also cover medical devices.

Policies providing for assistance for small and medium-sized enterprises and the Commission's calls for tenders might be equally relevant for the sector of medical devices.