Click here to subscribe to our YouTube Channel. Thanks.
Come join our LinkedIn discussion group to get up-to-date and actionable information on global medical device regulatory compliance. Click here to join.
EU Medical Directives / Regulations
- EU Medical Device Directive Consolidated 93/42/EEC (pdf)
- Europe Medical Devices Regulation - MDR
- In-Vitro-Diagnostics-Directive-98-79-ec-v2_0
- Europe In-Vitro Diagnostic Regulation - IVDR
- European Cosmetic Products Directive
- Regulation amending the European MDD 93/42/EEC and others
Click for MEDDEV Guidance Documents
Other EU Directives:
- OSHA List of Nationally Recognized Testing Laboratories (NRTL)
- List of SCC accredited bodies (Canada)
- EUROPA List of Notified Bodies under Nando
- CB Scheme
- List of ENEC members
- List of EU Harmonized Standards (MDD)
- List of EU Harmonized Standards (IVDD)
- List of EU Harmonized Standards (AIMD)
- List of EU Harmonized Standards (Machinery Directive)
- List of EU Harmonized Standards (REACH)
- List of EU Harmonized Standards (RoHS)
- List of EU Harmonized Standards (Packaging Directive)
- Just Published IEC Standards
- UL's Online Certifications Directories
- Intertek's Certified Products Directories
Standards: Coming soon!
- BSI Standards
- UL Standards
- ANSI Standards
- ISO Standards
- IEC Standards
- CSA Standards
- AAMI Standards
- NFPA Standards
- JIST Standards
#IEC60601 #ISO 13485 #ISO14971 #MDD #particular60601 #collateral60601 #FDA 510K #FDA PMA #MDD #CEMarking #Class I #ClassIIa #ClassIIb #riskassessment #riskanalysis #qualitymanagementsystem #compliance #medica devicedirective #machinerydirective #REACH #RoHS #lowvoltagedirective #93/42/EEC #QMS
