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- MDCG 2026-4: why manufacturers are becoming the managers of SS(C)Ps in EUDAMED
- EUDAMED: Four modules are now operational. Why this development is already changing the obligations of medical device manufacturers
- Borderline Manual v5: What Are the New Qualification and Classification Scenarios Under the MDR and IVDR?
- Fitness for use and risk management: how a manufacturer of motorized dental instruments secured its CE/FDA file thanks to an integrated approach
- MDR harmonized standards published in January 2026: what manufacturers really need to look at
- How long does an EUDAMED recording really take?
- Post-market surveillance (PMS) under MDR and IVDR: what the MDCG 2025-10 guide really changes for manufacturers
- The European Commission wants to simplify MDR and IVDR: what do manufacturers really need to understand?
- Breakthrough Devices (BtX): what does MDCG 2025-9 really change for medical device manufacturers?
- Eudamed really becomes operational: what Decision (EU) 2025/2371 changes for medical device manufacturers
- Clinics under the MDR: how to navigate between clinical evaluation, clinical investigation and applicable standards?
- MDCG 2025-8: how should optics manufacturers manage the Master UDI-DI?
- MDR: what does the transfer agreement published by Team-NB really change?
- Pilot coordinated assessment for CI/PS: a new step towards European coordinated assessment of clinical studies
- MedTech start-ups: how to get a CE marking project off to a good start?
- Biocompatibility and start-ups: how not to get lost in BEP, BER and TRA?
- ISO 13485 for start-ups: 3 realistic approaches
- Version 4 of the EU Borderline & Classification Manual: What Manufacturers Need to Know (September 2025)
- Submission of the IVDR Technical File: What Manufacturers Really Need to Get Right (Team‑NB, Sept. 2025)
- Combination products: bridges between ISO 13485 and ISO 15378 (and what the authorities expect)
- FDA vs MDR: 5 differences that matter to DM manufacturers
- IVDR and IVD Software: How to Properly Qualify and Classify Your Software
- CECP Procedure: What Should Medical Device Manufacturers Watch Out For?
- MDCG 2019-11 rev.1: What the New Version Changes for medical and IVD Software
- New MDCG 2025-4 Guidance: Requirements for Medical Device Software Apps on Online Platforms
- MDR CE marking: pitfalls to avoid as a start-up
- EUDAMED: Upcoming Obligations for Medical Device Manufacturers
- ISO 14971 and start-ups: how to get started on risk analysis without getting lost
- EUDAMED: which players (really) need to register? Deciphering the MDCG 2021-13 guide
- MIR Form v7.3.1: what manufacturers need to anticipate before November 2025
- EUDAMED v3.11.0 - What medical device manufacturers should know
- AI Act and medical devices: what manufacturers need to anticipate (Team-NB, 2025)
- MDR harmonized standards: April 8, 2025 update, what manufacturers need to remember
- MDR technical file submission: what manufacturers really need to take care of (Team-NB, April 2025)
- MD or not MD? What the ANSM guide to borderline cases really says (April 2025)
- Medicinal products used with a medical device: what does the EMA guideline on quality documentation have to say?
- ISO 14971, ISO/TR 24971, IEC 60812 and IEC 61025: how to choose the right risk analysis methods for medical devices
- Characterizing the risks of medical software: what should we learn from IMDRF guide N81 (2025)?
- Characterizing the risks of medical software: what should we learn from IMDRF guide N88 (2025)?
- 🇪🇺 EMDN Update 2025: What Medical Device Manufacturers Need to Know
- MDCG 2023-3 Rev.2: What Changes in Vigilance for MDs and IVDs in 2025?
- What is good regulatory support for a start-up?
- MedTech start-ups: where to begin preparing for CE marking?
- Publication of Clinical Investigation Reports: The MDCG 2024-15 Guide Explained
- MDCG 2024-14: Making Sense of Master UDI-DI for Contact Lenses
- Simplify Regulatory Compliance for AI-Powered Medical Devices with the Team NB and IG-NB Questionnaire
- MDCG 2023-3 Rev.1: New Vigilance Requirements for Medical Device and IVD Manufacturers
- Practical Guide: Submitting Technical Documentation under MDR (EU) 2017/745
- Q&A on Amendment 2024/1860 to MDR/IVDR: New Transparency and Safety Obligations for Medical Device Manufacturers
- MDCG 2022-5 revision 1 Guide: Clarification and Requirements for the Compliance of Medical Devices and Medicinal Products in Europe
- MDCG Guide 2024-13: What Medical Device Manufacturers Need to Know About Ethylene Oxide Sterilization
- Urgent Revision of MDR and IVDR in 2024: What Manufacturers Need to Know
- Revision of the MDCG 2021-25 Guide: What Medical Device Manufacturers need to know
- MDCG 2024-12: What It Means for Manufacturers in the Medical Device Industry
- New MDCG 2024-11 Guidance
- Complete Guide to MDR Codes: How to Use MDA, MDN, MDS, and MDT Codes for Medical Device Compliance
- MDR Documentation: Avoid Common Mistakes and Follow Best Practices
- Annexes II and III of the MDR: How to Create a Technical File to Obtain CE Marking for Your Medical Devices
- The AI risk repository
- Sun Tzu and Medical Devices
- CSDmed Supports Keenamics in Innovating Ankle Rehabilitation
- New Regulation (UE) 2024/1860
- New guide MDCG 2021-5 rev1 - Guidance on standardisation for medical devices
- Harmonized structure for IVD regulatory submissions
- MDCG 2024-10 Clinical evaluation of orphan medical devices
- Comprehensive Update on the Guidelines for Benefit-Risk Assessment of CMR/ED Phthalates in Medical Devices
- Methods Validation for Verification Testing in Medical Devices
- Insight into the Medical Devices Sector in 2023: Key Data and Trends
- Supercritical CO₂ Sterilization: An Eco-Friendly and Sustainable Alternative for Medical Devices
- Post Market Surveillance
- MDCG 2024-5 - guidance on content of the Investigator’s Brochure for clinical investigations of medical devices
- Successful and timely uptake of artificial intelligence in science in the EU
- Statement of Applicability according to section 6.1.3 of ISO/IEC 42001:2023
- How far can data support the transformation of health through AI?
- Competent authorities and medical devices registration
- Harmonized standards up to date in March 2024
- MDCG 2024-3 guidance - content of the Clinical Investigation Plan (CIP)
- NIS 2 Directive
- HLS structure within ISO-IEC 42001
- ISO and IAF Joint Communiqué about Climate Change
- EU Guide: EUDAMED overview and how to register your company
- IA act: France finally accepts the proposal, under conditions
- MDCG 2024-2 about update of EMDN codes
- language requirements for manufacturers
- NANDO base - situation on the 1st January 2024
- ISO 42001:2023 Artificial intelligence - Management system
- MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access to data needed to justify claims of equivalence
- MDCG 2019-07 Rev.1 (PRRC)
- MDCG 2021-27 Rev.1 - roles and responsibilities of importers and distributors of medical devices
- MDCG 2023-5 and MDCG 2023-6: two for the price of one - Products without an Intended Medical Purpose under Annex XVI
- New release: MDCG 2021-6 Rev. 1 - Questions & Answers regarding clinical investigation
- (EC) 2023/2482 amending Regulation (EC) No 1907/2006
- New issue of the MDCG Position Paper : MDCG 2022-11 revision 1 - Notice to manufacturers and NB
- Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics
- Implementing Regulation (EU) 2022/2346 and (EU) 2023/1194 of the arrangements in Annex XVI of MDR 2017/745 - risk management and transitional provisions
- The calendar according to amending regulation 2023/607
- Guidance on machine learning-enabled medical devices (MLMD)
- New amending document for EU MDR 2017/745: the EU 2023/2197
- New MDCG 2023-4 guidance: Medical Device Software (MDSW) - Hardware combinations
- Medical devices classification
- New manual on borderline and classification for medical devices
- What is a medical device ?
- New issue of the FDA Guidance : Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
- Understanding the Imperative of Risk Management Plan (RMP) in Medical Devices
- The hidden risks of sourcing medical equipment from China
- Exciting News! CSDmed is Now a Member of the AFNOR Adherents Club
- Come, find and meet us during the 11th edition of "la rentrée du DM" at the Kursaal of Besançon.
- MDR 2017/745 consolidated with regulations 2023-607 and 2020-561
- MDCG 2023-1 - Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- Extension of transitional period of Medical Device Regulation (MDR 2017/745)
- MDCG 2022-16 Guidance on Authorised Representatives under MDR and IVDR
- MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation - December 2021
- MDCG 2021-24 Guidance on classification of medical devices - October 2021
- IFU and information provided by the manufacturer: how to align MDR, ISO 20417 and ISO 15223-1?
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