Website for EU Study

European Commission site

Europa – the European Union Online

Eur-lex home

Enterprise Medical Devices Guidelines

Belgian Competent Authority (CA)

UK CA, devices

UK CA, drugs – has very good links to other EU CAs websites

German CA, drugs and devices

Irish CA

EMEA welcome Page

French CA, drugs and devices

Regulatory Affairs Professionals Society

Association of British Healthcare Industries

European Confederation of Medical Device Associations

European Diagnostic Manufacturers’ Association

International Standards Organisation

British Standards Institution – good search function

French Standards body

New Approach home page

List of all New Approach directives and related harmonised standards
and standards activity at

International Conference on Harmonization-drug and biologics standards

Global Harmonization Task Force – Device Standards and guidelines

International Federation of Pharmaceutical Associations – has links
to many national pharma trade associations, including US

Reg source EU page – many links

CEN standards site

Cenelec standards site

IEC standards site

TNO site (Notified Body)


Medicinal sites, EU

1. EU. Rules and regs

2. Clinical Trials

3. National agencies. (the links section also has links to ICH, EMEA,
etc. )

4. Industry orgs, this links page has most. Scroll down to industry
orgs. also has links to most EU agencies and worldwide agencies. TOPRA
home is also interesting.

5. ICH

6. Vigilance

7. Guidances



Device and Medicinal

1. European Commission site:

2. Europa-the European Union Online:

3. Eur-lex home:

4. Enterprise Medical Devices Guidelines:

5. Belgian Competent Authority (CA):

6. UK CA, -has very good links to other EU CAs websites:

7. German CA, drugs and devices:

8. EMEA welcome Page:

9. French CA, drugs and devices:

10. Regulatory Affairs Professionals Society:

11. Association of British Healthcare Industries:

12. European Confederation of Medical Device Associations:

13. European Diagnostic Manufacturers’ Association:

14. International Standards Organization:

15. British Standards Institution – good search function:

16. French Standards body:

17. List of all new approach directives:

18. Related harmonised standards and standards activity:

19. Global Harmonization Task Force-Device Standards and guidelines:

20. International Federation of Pharmaceutical Associations-has links
to many national pharma trade associations, including US:

21. Reg source EU page-many links: