The latest posts about #EU

Opportunities for Smaller Software Developers Highlighted by MDCG
Feb 21, 2023
10
min read
Extension of MDR Transition Proposed by European Commission
Jan 17, 2023
5
min read
MDCG Proposes a Potential One-Year Extension for Medical Devices
Jan 10, 2023
5
min read
Medical Device Production Systems a Significant Regulatory Undertaking
Dec 6, 2022
10
min read
IMDRF Issues Two-Part Guidance for Personalized Medical Devices
Nov 29, 2022
10
min read
ICH Expands on Analytical Methods Validation in Draft- Q2 Update
Sep 22, 2022
5
min read
Terms and Definitions Drive Concerns Over FDA’s Quality Systems Proposal
Aug 22, 2022
5
min read
MDCG Warning Letter to Industry: No More MDR Delays
Aug 3, 2022
5
min read
IMDRF Lays Groundwork for Harmonized Machine Learning Regulation
Jul 5, 2022
5
min read
Regulatory Framework Comparison Series: Software as a Medical Device
Jun 21, 2022
10
min read
Regulatory Framework Comparison Series: Risk Management
Jun 7, 2022
5
min read
Regulatory Framework Comparison Series: Post Market Devices
Jun 1, 2022
5
min read
EU and FDA Policies in Conflict over Product Designation
May 10, 2022
10
min read
Stream of MDCG Guidances Continues in 2022
Mar 29, 2022
10
min read
Clarity of Intended Use a Key Point in IVDR Device Classification
Nov 10, 2021
5
min read
EU Draft Legislation for AI May Add Regulatory Hurdles
Jun 18, 2021
10
min read

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