Regulation (EU) 2017/745 EU MDR requirements Fresenius Medical Care is committed to ensuring that all our medical devices meet the applicable MDR requirements in accordance with the respective transitional timelines. Many questions arise concerning the MDR, regarding: ...
Euractiv Intelligence Health Medical devices regulation Jan 1, 201300:000 min. readContent type:Euractiv is part of the Trust Project Print Share Supporters Advertisement More from this section Browse all articles Health 23/01/2025 3 min. read ...
EuropeMDRMedical Device RegulationMedical DevicesMedical device (MD) is a broad term that encompasses products ranging from, for example, examination gloves to digital dermoscopy systems; all of which are regulated by a new regulatory framework in the EU from May 2021. The new Medical Device ...
1. European Union Medical Device Regulation (EU MDR) Intro 2. Classification of Devices 3. Explanation of Economic Operators 4. The General Safety and Performance Requirements (GSPR) 5. Requirements for the Technical File 6. Risk Management Requirements Unique to the EU MDR ...
For implantable devices, check whether the mandatory information to be supplied to the patient (including the implant card) complies with the MDR and hedges your company sufficiently against product liability risks. For devices that incorporate electronic programmable systems, inc...
What is the European Union’s (EU) Medical Device Regulation (MDR)? What is new about the European Union’s (EU) Medical Device Regulation (MDR)? MasterControl Regulatory Compliance Software Reviews Almost guaranteed compliance "They've considered all they can to ensure compliance with North Amer...
Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) have been published in the Official Journal of the European Union today. The Regulations will enter into force on May 26th, marking the start of the transition period for manufacturers selling medical ...
Device Advice & CERs can help your company with a wide range of regulatory and clinical evaluation support for medical devices in Europe, UK and Australia.
Medical devices regulationStandardsAfricaEuropeOpen Source Medical DevicesHarmonization across the two continents could be leveraged to optimize the costs of device manufacture and sale. Regulated open design strategies can enhance economically sustainable innovation....
To assist you in placing your medical devices onto the EU market, Eurofins E&E has a number of Notified Bodies (NB) that can provide conformity assessment to the Medical Device Regulation (MDR) 2017/745 as well as to the In-Vitro Diagnostic Regulation (IVDR) 2017/746. Medical Device Regulat...