Regulations — Full Text
Searchable full text of key medical device and IVD regulations.
EU MDR
Full English text of the European Medical Device Regulation
Preamble & Recitals›Chapter I — Scope and Definitions›Chapter II — Making Available and Putting into Service›Chapter III — Identification and Traceability (UDI)›Chapter IV — Notified Bodies›Chapter V — Classification and Conformity Assessment›Chapter VI — Clinical Evaluation and Investigation›Chapter VII — Post-Market Surveillance›Chapter VIII — Cooperation Between Member States›Chapter IX — Confidentiality and Data Protection›Chapter X — Final Provisions›
EU IVDR
Full English text of the European In Vitro Diagnostic Regulation
Preamble & Recitals›Chapter I — Scope and Definitions›Chapter II — Making Available and Putting into Service›Chapter III — Identification and Traceability (UDI)›Chapter IV — Notified Bodies›Chapter V — Classification and Conformity Assessment›Chapter VI — Performance Evaluation and Studies›Chapter VII — Post-Market Surveillance›Chapter VIII — Cooperation Between Member States›Chapter IX — Confidentiality and Data Protection›Chapter X — Final Provisions›
FDA
Key FDA regulations for medical device manufacturers