№ lp_1_2_58985
This document provides guidance on the overlap between the 2017 EU Medical Device Regulation (MDR) for software and the NICE Evidence Standards Framework (ESF) for digital health technologies (DHTs), aimed at helping DHT developers understand the evidence requirements for both MDR and ESF.
Year: 2020
Region / city: United Kingdom
Topic: Medical device regulations, digital health technologies
Document type: Guidance document
Organization / institution: Newcastle upon Tyne Hospitals NHS Foundation Trust External Assessment Centre (EAC)
Author: Ina Guri, Alison Bray, Michael Drinnan
Target audience: Developers of digital health technologies, medical device manufacturers
Period of validity: Ongoing
Approval date: 23 October 2020
Date of changes: N/A
Price: 8 / 10 USD
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