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New Regulations - Public Health
- https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
- The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. The priority was to ensure a robust, transparent and sustainable regulatory framework and maintain a high level of safety, while supporting innovation. Two new … See more
Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …
The revision of the EU Medical Devices Directives
- 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 critical provider of innovative, …
The European Union Medical Device Regulation – …
- https://eumdr.com/
- The European Commission published IMPLEMENTING DECISION (EU) 2019/939, designating four entities to assign Unique Device Identifiers (UDIs) to medical devices …
Directives - Public Health
- https://health.ec.europa.eu/medical-devices-sector/directives_en
- Implementing measures for directives. The European Commission has adopted several implementing measures based on the medical devices directives. These measures …
Medicines and Medical Devices | Fact Sheets on the …
- https://www.europarl.europa.eu/factsheets/en/sheet/50/geneesmiddelen-en-medische-hulpmiddelen
- In the 2021 negotiations on Regulation (EU) 2021/2282 on health technology assessment, Parliament was keen to ensure that health technology assessment would be used to …
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 …
The revision of the EU Medical Devices Directives
- https://www.fdanews.com/ext/resources/files/04/04-14-Eucomed.pdf
- revision of the EU Medical Devices Directives (MDD), and acknowledge their importance in achieving the above mentioned objectives. In this position paper, we wish to focus on …
Medical device directives revision: variations in national laws
- https://medtech.pharmaintelligence.informa.com/MT096434/Medical-device-directives-revision-variations-in-national-laws
- How successful have the EU member states been in implementing the revision of the medical device directives into national law? And has this been done in …
Revision of the EU Directive on in vitro giagnostic …
- https://www.ema.europa.eu/en/documents/presentation/presentation-revision-european-union-directive-vitro-diagnostic-medical-devices_en.pdf
- diagnostic medical devices: horizontal issues • 5. Governance of the system - Creation of a statutory Medical Device Coordination Group composed of experts designated by the …
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