Scottish Health Innovations Ltd (SHIL) works in partnership with NHS Scotland to identify, protect, develop and commercialise new innovations from healthcare professionals. Registered Number: SC 236303. Registered address: The Golden Jubliee National Hospital, Fourth Floor East, Agmemmon St, Clydebank, G81 4DY
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To allow health authorities and manufacturers to focus entirely on Coronavirus (COVID-19), new approval rules for medical devices are to be postponed by one year.
New European regulation were due to come into force on Tuesday 26 May. It has now been proposed by both the European Commission and Parliament to postpone by one year until Wednesday 26 May 2021. A statement by the Parliament on the decision said:
“Given the current pressure on national health authorities and manufacturers of medical devices, there is a fear that there could be shortages or delays in getting the medical devices needed to fight COVID-19, were they to follow the new rules of the Medical Devices Regulation from May this year.”
The proposal now also has to be approved by the EU member states and published in the Official Journal before it will enter into force. This is expected at the latest by Tuesday 26 May.
European legislation ensures that medical devices are safe to use and facilitates patients’ access to devices on the European market.
In 2017, two new regulations on medical devices and in vitro diagnostic medical devices were adopted to improve patient safety and increase transparency on medical devices across the EU. The new regulation for medical devices was supposed to be fully applicable on 26 May 2020. The date of application of the In Vitro Diagnostics Medical Devices Regulation is not affected by the new proposal and becomes applicable from Thursday 26 May 2022, as planned.
Scottish Health Innovations Ltd (SHIL) provides regulatory advice to NHS Scotland, plus companies or universities working in partnership with NHS Scotland to develop medical devices. Any queries related to developments on Medical Device Regulation and the In Vitro Diagnostics Medical Devices Regulation can be sent to firstname.lastname@example.org.