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EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Medical Products and Innovation
Medical Devices
MDR - language requirements for manufacturers Rev. 1 (March 2
30.03.2026
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Work Programme of MDCG Borderline and Classification subgroup 2023
Last update: 21 November 2023
This document sets out the work program of the MDCG B&C Working Group for 2023. There are a number of
30.03.2026
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Ongoing guidance development and deliverables of MDCG Subgroups – March 2023*
*This is not an exhaustive list of ongoing work performed by MDCG Subgroups
Scope Group Deliverables
Consult
30.03.2026
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Medical Device Coordination Group Document MDCG 2024-12
applicable for M
30.03.2026
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Medical Devices
Medical Device Coordination Group Document MDCG 2024-10
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MDCG 2024-10
Clinical evaluation of orphan
medical devices
June 202
30.03.2026
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Medical Device
Medical Device Coordination Group Document MDCG 2024-5
MDCG 2024-5
guidance on content of the Investigator’s Brochure for
clinical in
30.03.2026
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Medical Devices
Medical Device Coordination Group Document MDCG 2024-4
Page 1 of 23
MDCG 2024-4
Safety reporting in performance studies of in vitro
diagnostic medical de
30.03.2026
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Medical Devices
Medical Device Coordination Group Document MDCG 2024-1-5
MDCG 2024-1-5
Guidance on the vigilance system
for CE-marked devices
DSVG
30.03.2026
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Medical Device
Medical Device Coordination Group Document MDCG 2023-7
1(12)
MDCG 2023-7
Guidance on exemptions from the requirement to
perfor
30.03.2026
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Medical Devices
Medical Device Coordination Group Document MDCG 2023-6
Page 1 of 4
MDCG 2023-6
Guidance on demonstration of
equivalence for Annex XVI products
A guide
30.03.2026
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