HPRA Medical Devices Newsletter - Issue 50 - April 2020
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hpra-medical-devices-newsletter---issue-50---april-2020.pdf
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Published: 9 April 2020
In this issue
HPRA Updates
- COVID-19: Medical Devices Update
- Overview of Testing Strategy
- National Derogation for Covid-19 Critical Devices
- Regulation of Hand Sanitiser and Face Masks
- In-House Manufacturing of In-Vitro Diagnostic Medical Devices
- HPRA Process for Certificates of Free Sale
EU Cooperation
- Commission Proposal to Delay Implementation of the MDR
- Notified Bodies - ‘State of Play’
- MDCG Endorsed Guidance Documents
- Recently endorsed documents- March 2020
- Guidance for Class I Manufacturers
- Register of Economic Operators and Devices under the EU Device Regulations
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