Regulatory references
A practical guide to the most important standards and regulations in the medical sector
REGULATIONS
The Regulations section has been created to provide a clear and accessible glossary of the laws, guidance and official documents most frequently referenced across our services and throughout this website.
The aim is to make complex regulatory concepts easier to understand and to offer a quick reference point for professionals, companies and sector operators.
Here you will find concise yet accurate explanations of:
• European Regulations: MDR 2017/745 and IVDR 2017/746
• GSPR – General Safety and Performance Requirements
• MDCG guidance documents
• The Blue Guide and the New Legislative Framework (NLF)
• IMDRF documents and international references
These summaries do not replace the official documents. They are intended to help you navigate more quickly and understand the regulatory context underpinning projects, processes and business decisions.
Insights
REGULATORY REFERENCE LIBRARY
A curated collection of technical resources and informational updates to help you stay aligned with the regulatory and procedural requirements governing European markets.
MDCG guidance: what it is and why it is essential
MDCG (Medical Device Coordination Group) guidance documents are official EU publications that support the practical interpretation of the MDR/IVDR. They are not legally binding, but they represent a key technical reference for manufacturers, notified bodies and other...
MDR 2017/745: a clear overview of the European Medical Devices Regulation
Regulation (EU) 2017/745 (MDR) is the legal framework that governs all medical devices placed on the European market today. Fully applicable since 26 May 2021, it replaced Directive 93/42/EEC (MDD), introducing significantly more stringent requirements in terms of...
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