The Batteries Regulation is horizontal EU legislation and applies regardless of MDR or IVDR compliance, which is something many companies in the devices do not realise. Non-compliant battery leads to a non-compliant device, and there is your conundrum. We spent a lot of time in Q4 2024 helpin...
Medical device companies are now "playing catch-up" when it comes to preparing and showing compliance with RoHS-type legislation. From parts shortages to parts with incorrect finishes, there are many lessons to be learned from other industries when responding to RoHS-type laws. The medical ...
Ms. Elaine Lyu is a Senior consultant in the Medical Device Legislation Compliance Department ofCIRS, she gained her master degree (Advancing Practice) from University of Worcester. Elaine has extensive background in China medical device regulatory activities by developing compliance procedures for medica...
6. Ensuring audit and inspection readiness 7. Plan to handle unannounced audits 8. Strengthen post-market surveillance activities 9. Unique device identifier (UDI) & EUDAMED 10. Requirements for “in-house devices” References An exhaustive guide to regulatory compliance for IVD manufacturers, written...
MedicalDeviceCoordinationGroupDocumentMDCG2021-5Rev.1 Guidanceonstandardisationformedicaldevices Introduction:scopeandcontents Thisdocumentaimstoprovideguidanceondifferentaspectsrelatedtostandardsinthemedical devicessectorinsupportoftherequirementslaiddownintheapplicableEUlegislation,taking ...
医疗器械分类的目的 The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with thedevices.Thisapproachusesa set ofcriteriathat canbecombinedin variouswaysin ...
Medical Devices MDCG 2021- 24 Medical Device Coordination Group Document 1 Purpose of medical device classification The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks...
Device claims are a part of the advertising and promotion of a product which, in the European Union, are regulated by MDR 201/745, along with several EU directives, and the legislations of the individual EU Member States. Article 7 of the MDR outlines the requirements for medical device cl...
Medical device live and on demand webinars We offer a wide range of free and live webinars hosted by BSI Technical Specialists addressing key topics that affect your business including legislation, risk, and regulatory changes. Select an upcoming webinar below to register your interest. ...
Work smarter with the only platform designed by regulatory experts to manage your compliance process. Compliance Navigator is the only digital, multi-user platform currently available for managing the compliance process for medical device and in-vitro diagnostics products. ...