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MDR vs. MDD: 13 Key Changes - The FDA Group
- https://www.thefdagroup.com/blog/mdr-vs-mdd-13-key-changes
- Europe's new Medical Devices Regulation (MDR) will bring significant regulatory changes that may impact multiple business units within your organization. The date of application (DoA) of the EU Medical Devices Regulation (EU MDR) has been …
Revision of the medical device regulatory framework
- https://www.bsigroup.com/en-AE/medical-devices/our-services/MDR-Revision/
- The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three …
Medical Devices Directive 93/42/EEC is due …
- https://www.cti-cem.com/blog/medical-devices-directive-93-42-eec/
- The Directive excludes any products which come within the scope of one of the other two medical device …
The revision of the EU Medical Devices …
- https://www.medtecheurope.org/resource-library/the-revision-of-the-eu-medical-devices-directives/
- The revision of the EU Medical Devices Directives The European medical device industry is a …
MEDDEV 2.7/1 revision 4, Clinical evaluation: a …
- https://www.medical-device-regulation.eu/wp-content/uploads/2019/05/2_7_1_rev4_en.pdf
- The medical device legislation in Europe is currently being significantly revised. A new Regulation of the European Parliament and of the Council on medical devices will be …
What’s changed compared to the MDD – The European …
- https://eumdr.com/whats-changed/
- On 26 May 2021 the EUMDR entered into application and the MDD was repealed. The new EU Medical Device Regulation (EU MDR) is not radically different from the current …
Medical device directives revision: variations in national laws
- https://medtech.pharmaintelligence.informa.com/MT096434/Medical-device-directives-revision-variations-in-national-laws
- The revision of the EU medical device directives and variations in national laws How successful have the EU member states been in implementing the revision of …
Medical Device Directives
- https://www.abhi.org.uk/what-we-do/regulation/medical-device-legislation/medical-device-directives/
- Medical Device Directives Medical Devices have been regulated by three European Union Directives since the early 1990’s. They cover: Active implantable medical …
Medical Devices Directive - Wikipedia
- https://en.wikipedia.org/wiki/Medical_Devices_Directive
- The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws …
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