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https://www.newzealandhealthcarenews.com/article/883830813-sirius-medical-achieves-certification-according-to-eu-mdr-and-expanded-indications-for-pintuition
Sirius Medical Achieves Certification according to EU-MDR and Expanded Indications for Pintuition®...
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https://en.medtecchina.com/media/policies-regulations/how-major-medtech-companies-are-responding-to-the-looming-eu-mdr/
How major medtech companies are responding to the looming EU MDR - Medtec China
Nov 15, 2020 - Medtech companies that sell products in the European Union have a major deadline looming — one that’s already been put off once....... Read More
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https://emmainternational.com/the-swixit-dilemma-for-medtech-part-ii/
Swiss Medtech Transition Plan for EU MDR
May 10, 2023 - Learn about Swiss Medtech's transition plan in case a mutual recognition agreement is not reached for the EU Medical Device Regulation.
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https://acohealthcare.com/acquired-eu-mdr-certification/
Aco Healthcare Acquired EU MDR Certification: A Milestone for Innovation and Patient Safety - Aco...
Sep 12, 2025 - We are thrilled to announce that Aco Healthcare has officially received CE MDR (Medical Device Regulation) Certification. This accomplishment represents a...
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https://www.marketscale.com/industries/business-services/topic/eu-mdr-extension
Eu Mdr Extension: Business Services Articles | MarketScale
1 article on Eu Mdr Extension in Business Services, from the practitioners and experts doing the work, published on MarketScale.
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https://www.emergobyul.com/news/european-mdr-amendment-what-expect-and-when
Q&A document on amendment to extend EU MDR transition timeframes
As a representative of the European Association of Authorized Representatives (EAAR), Emergo by UL joined a workshop on the practical implementation of the...
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https://surgicalgloves.com/category/resources/standards-compliance/
Surgical Glove Standards: EN 455, FDA 510(k) & EU MDR | HBM
Medical device compliance for surgical gloves explained: EN 455, FDA 510(k), EU MDR and ISO 13485 - what buyers must verify before sourcing.
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https://www.makrocare.com/tag/eu-mdr-cer/
EU MDR CER
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https://cyberintelsys.com/eu-mdr-fda-510k-security-testing-services-for-remote-patient-monitoring-wearable-in-kenya/
EU MDR / FDA 510(k) Security Testing Services for Remote Patient Monitoring Wearable in Kenya
Jun 20, 2026 - Ensure EU MDR and FDA 510(k) compliance with advanced security testing services for Remote Patient Monitoring Wearable devices in Kenya, aligned with global...
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https://www.sterlingmedicalregistration.com/store/management-review-procedure
titleManagement Review Procedure | FDA QMSR ISO 13485 EU MDR...
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https://ziuma.com/Thread-How-Does-EU-MDR-Penetration-Testing-Identify-Risks-in-SaMD-and-Class-II-III-Devices?pid=72819
How Does EU MDR Penetration Testing Identify Risks in SaMD and Class II/III Devices?
Preparing a medical device to meet the EU MDR requirements can be difficult in some cases. It can be challenging when cybersecurity testing doesn’t cover its...
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https://www.regulatorymedicaldevice.com/2024/06/guidance-on-biological-risk-assessment-CMR-substances-phthalates-in-medical-devices.html
Guidance on Biological Risk Assessment, CMR Substances, and Phthalates under EU MDR 2017/745
A critical aspect of this regulation is the assessment of biological risks, particularly focusing on the presence of carcinogenic, mutagenic, or toxic
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https://pharmadocx.com/eu-mdr-udi-requirements/
EU MDR UDI Requirements: Everything You Need to Know - Pharmadocx Consultants
Nov 13, 2025 - EU MDR UDI requirements. Elements of the UDI system. Roles of manufacturers and distributors in UDI compliance. EUDAMED registration of UDI.
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https://www.deltapyramax.com/total-solutions/tag/EU+MDR
EU MDR — Total Solutions | Explore Sustainable Solutions Today — Delta Pyramax Co., Ltd.
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https://www.pharmatomarket.com/singapore-hsa-published-document-relating-to-change-applications-arising-from-the-eu-mdr-ivdr-related-changes-to-registered-medical-devices/
Singapore HSA Published Document Relating to Change Applications Arising from the EU MDR/IVDR...
Nov 26, 2020 - With EU’s recent regulatory framework transition to Medical Devices Regulation (MDR) and IVD Regulation (IVDR), the related changes will impact ...
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https://europeancompliancesuite.com/eu-mdr-compliance/
EU MDR Compliance - Medical Device Regulation
Aug 6, 2026 - EU MDR compliance explained. Discover your obligations and let MDR consultancy sort out your compliance.
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https://meddeviceguide.com/blog/medical-device-udi-labeling-legal-text-comparison-guide
UDI & Labeling Compared: FDA 801/830, EU MDR, Mexico NOM-137 & China | MedDeviceGuide
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https://www.biospace.com/ikerian-parent-company-of-retinai-u-s-inc-receives-eu-mdr-certificate-for-four-devices-its-ophthalmology-data-platform-and-ai-models
Ikerian (parent company of RetinAI U.S. Inc.) receives EU-MDR Certificate for four devices, its...
Jul 17, 2024 - Ikerian AG (“Ikerian”) a leader in developing software solutions for medical image and data management and artificial intelligence (AI) in healthcare, today...
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https://www.china-check.com/es/guides/importing-medical-vaporizers-from-china-eu-mdr-fcc-compliance-and-electronics-so
Importing Medical Vaporizers from China: EU MDR, FCC Compliance, and Electronics Sourcing Tips |...
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https://mantrasystems.com/enable-ce-mark/technical-document-templates/annex-ii-templates
EU MDR Annex II Templates | Mantra Systems
The comprehensive solution to producing EU MDR Annex II technical documents for your medical devices.
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https://www.mastercontrol.com/fr/compliance/eu-mdr/
EU MDR | Règlement relatif aux dispositifs médicaux | MasterControl
Comment se préparer aux changements à venir en matière de réglementation européenne sur les dispositifs médicaux ?
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https://www.teklynx.com/de-EMEA/blog/eu-mdr-labeling-software
Comply With EU MDR Labeling Software | TEKLYNX Blog
Learn how EU MDR labeling software helps companies comply and improve their labeling process.
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https://www.greenlight.guru/blog/distributor-requirements-eu-mdr-ivdr
EU MDR and IVDR Distributor Requirements [Overview]
This article explains the role of a distributor under the new MDR and IVDR regulations, as well as reviewing the responsibilities of distributors in regards to...
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https://www.yofomedical.com/news/pirox-achieves-eu-ce-certification-following-fda-510k-clearance
Pirox Achieves EU MDR Certification & FDA 510(k) Clearance | Yofo Medical
Yofo Medical's Pirox achieves EU MDR certification following FDA 510(k) clearance, strengthening regulatory access for its advanced dental CBCT technology in...
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https://www.bsigroup.com/en-IL/insights-and-media/insights/whitepapers/eu-mdr-post-market-clinical-follow-up/
EU MDR – Post Market Clinical Follow-Up | BSI
This whitepaper aims to guide the medical device manufacturer in the implementation of real-world data collection as part of PMCF.
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https://www.eclevarmedtech.com/de/mdcg-2021-8-dokumente-fuer-die-beantragung-oder-notifikation-einer-klinische-pruefung/
MDCG 2021-8 Dokumente für Klinische Prüfungsanträge - EU MDR
Übersicht der MDCG 2021-8 Dokumente für klinische Prüfungsanträge nach EU MDR 2017/745 in Deutschland. Eclevar MedTech CRO.
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https://medtechintelligence.com/column/ask-the-expert-eu-mdr-as-a-trigger-for-innovation/
Column - Ask the Expert: EU MDR as a Trigger for Innovation - MedTech Intelligence
Apr 22, 2024 - EU MDR has increased the regulatory burden for medical device companies, but it can also serve as a catalyst for innovation and an opportunity to streamline...
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https://medtechspectrum.com/news/64/25246/cynosure-lutronic-announces-completion-of-eu-mdr-approval-and-global-momentum-for-mosaic-3d.html
Cynosure Lutronic Announces Completion of EU MDR Approval and Global Momentum for Mosaic 3D
Cynosure Lutronic Announces Completion of EU MDR Approval and Global Momentum for Mosaic 3D
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https://www.paconsulting.com/newsroom/med-device-online-overcoming-challenges-to-sustain-certification-19-march-2024
Navigating EU MDR compliance: Overcoming challenges… | PA Consulting
How manufacturers of medical devices can overcome certification challenges.
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https://hl-associates.in/global-services/ce-marking-eu-mdr/
CE Marking (EU MDR/IVDR) | HL Associates
Strategic consulting for CE Marking compliance under the European Union Medical Device Regulation (EU MDR 2017/745).
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https://podcast.easymedicaldevice.com/215-2/
Breaking News: EU MDR Extension Proposal is out for consultation
Jan 17, 2023 - The EU MDR Extension Proposal is released and will be voted soon. Let's look with Erik on what are the surprises inside.
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https://www.orielstat.com/consulting/New-EU-Medical-Device-Regulation
EU MDR: Implementation of the European Medical Device Regulation 2017/745
The new European MDR went into effect May 2021. Learn how ELIQUENT Life Sciences (formerly Oriel STAT A MATRIX) has helped medical device professionals comply...
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https://www.bsigroup.com/en-PH/insights-and-media/media/webinars/eu-mdr-rule-21/
EU MDR Rule 21 | BSI
Understand EU MDR Rule 21's impact on medical devices. Learn key adaptation strategies for compliance.
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https://servicenextwest.wbresearch.com/blog/what-eu-mdr-ivdr-mean-for-future-compliance-in-the-medical-device-industry
What EU MDR & IVDR Mean for Future Compliance in the Medical Device Industry
Service Next West 2027
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https://meddeviceguide.com/blog/benefit-risk-analysis-medical-device-fda-eu-mdr-iso-14971-guide
Benefit-Risk Analysis for Medical Devices: FDA, EU MDR, and ISO 14971 Decision Framework |...
Apr 24, 2026 - Guide to medical device benefit-risk analysis, covering ISO 14971 residual risk, EU MDR AFAP expectations, FDA benefit-risk factors for PMA, De Novo, and...
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https://www.purdiepascoe.com/news-views/purdie-pascoe-leads-the-way-on-eu-mdr-compliance
Purdie Pascoe leads the way on EU MDR Compliance — Purdie Pascoe
By the 26th of May 2020 the EU’s Medical Device Regulations (EU MDR) will require manufacturers to adhere stricter regulations to ensure that their devices are...
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https://tandemhealth.ai/da/ressourcer/indsigt/eu-mdr-klassifikation-hvilke-ai-vaerktoejer-praktiserende-laeger-kan-implementere
EU MDR-klassifikation: Hvilke AI-værktøjer praktiserende læger kan implementere | Tandem Health
Forstå EU MDR-klassifikation for AI-værktøjer i almen praksis. Lær, hvilke værktøjer der kræver CE-mærkning, operatørforpligtelser, og hvordan du vurderer...
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https://www.freyrsolutions.com/es/success-stories/transforming-eu-mdr-complaint-handling-into-an-audit-ready-post-market-framework
Gestión de reclamaciones del EU MDR y cumplimiento posterior a la comercialización | Freyr
Descubra cómo Freyr transformó la gestión de reclamaciones del EU MDR en un marco posterior a la comercialización preparado para auditorías con el fin de...
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https://complyguru.com/training/eu-mdr-requirements-course/
EU MDR Training on Requirements - IRCA Certified
Aug 18, 2026 - EU MDR Training on requirements of the European Medical Device Regulation (2017/745) for those are new to the requirements. IRCA Certified. Register Today!
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https://mdregulatory.com/clinical-evaluation-training-course/
Clinical Evaluation according to EU MDR 2017/745 — MD Regulatory Academy
Aug 20, 2026 - Article 61 · Annex XIV · Annex XV
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https://mdregulatory.com/product/cdp-template-mdr/
Clinical Development Plan (CDP) Template — EU MDR (Word)
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https://www.raps.org/learn-develop/events/wisconsin-chapter-ensuring-your-qms-is-ready-for-eu-mdr.html
Wisconsin Chapter: Ensuring Your QMS is Ready for EU MDR | RAPS
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https://neuralynx.fh-co.com/fhc-inc-announces-eu-mdr-certification-of-atlas-neurophysiology-system/
FHC, Inc. Announces EU MDR Certification of ATLAS™ Neurophysiology System - NeuraLynx
Jun 11, 2026 - Bowdoinham, ME — June 10, 2026 — FHC, Inc., a leading manufacturer of precision medical devices for neurosurgery and neuroscience research, today announced
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https://www.medical-valley-emn.de/veranstaltungen/post-market-surveillance-vigilance-ensuring-safety-compliance-and-market-success-under-eu-mdr-2/
Post-Market Surveillance & Vigilance: Ensuring Safety, Compliance and Market Success under (EU) MDR...
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https://lne-gmed.com/training/clinical-evaluation-requirements-cer
CER Report Requirements Under EU MDR 2017/745 - GMED NA
Sep 17, 2026 - Explore GMED's Clinical Evaluation Report (CER) Requirements Under EU MDR 2017/745 training course to help companies seamlessly manage the CER process.
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