Glossary key term references are listed below.
Key Term References
There are currently 2 references in this directory beginning with the letter E.
EU IVDR 2017/746
In Vitro Diagnostic Medical Device Regulation
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
EU MDR 2017/745
Medical Device Regulation
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
- US (FDA and OLRC) regulations, US FDA guidance documents, European (EU) regulations, and IMDRF documents are available online for free.
- International (ISO and IEC) standards are available for purchase from ISO or IEC, and in some cases, a preview or read-only version may be available online for free.
- American (US) versions of international medical device standards are available for purchase from AAMI which offers significant discounts for AAMI members.
- Other national versions of international standards are available for purchase from national standards bodies.
For an introduction to medical device standards and regulations, view online video Course 250 – Regulatory Compliance.