Medical Devices | Monthly bulletin | March 2020
Regulatory news
New European Commmission guidance on medical device nomenclature and cybersecurity
In January 2020, the European Commission published several documents on European Medical Device Nomenclature and cybersecurity with the aim of clarifying requirements in relation to the nomenclature to enter product information into Eudamed and pre-market and post-market cybersecurity requirements. The documents are:
- The European Medical Device Nomenclature (EMDN) - the nomenclature of use in EUDAMED
- The CND Nomenclature - background and general principles
- MDCG 2019-16 - Guidande on Cybersecurity for medical devices
Standards updates
Please see below a table summarising outlining some recent standards updates and upcoming dates of withdrawal (non-exhaustive):
(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.
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CENELEC/CEN |
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|
Reference |
Title |
Date of Withdrawal (*) |
Supersedes |
|
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019) |
2023-01-31 |
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|
IEC Standards |
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Reference |
Title |
Publication date |
|
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
01-17-2020 |
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Regulatory proposals notified to WTO
Please see the below table summarising the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):
|
Notification number |
Countries |
Title |
|
US |
Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer
The Food and Drug Administration (FDA) is classifying the radiological computer-assisted diagnostic (CADx) software for lesions suspicious in terms of cancer as class II (special controls) |
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|
US |
Medical Devices; Radiology Devices; Classification of the Radiological Computer Aided Triage and Notification Software
The Food and Drug Administration (FDA) is classifying the radiological computer aided triage and notification software as class II (special controls) |
