Clinical investigations of medical devices – guidance for manufacturers from the MHRA, covers everything from the choice to conduct a clinical trial to the approval process. CLIN-r+ gives you an overview and highlights key aspects to help you understand UK clinical investigation legislation if you plan to conduct one.
Medical device safety and performance can be demonstrated via clinical investigations. The Medical Device Coordination Group amended MDCG 2021-6 clinical investigation recommendations in December 2023. CLIN-r+ outlines both new and revised questions and answers.
Conformity routes under the clinical data needs for the EU MDR are not well understood and can lead to unnecessary costs due to investment into clinical investigations or unsuccessful CE assessments. CLIN-r+ outline the clinical evaluation route options, their requirements, and which devices they apply to.
Consultancies vs agencies – they’re all the same, right? Actually, no. There are quite big differences between the two, and some of them might be surprising. We provide a comparison to ensure that manufacturers can make informed decisions about who they work with and why.
Non-conformances (NCs) and non-conformance reports (NCRs) are important for medical device manufacturers to understand and manage correctly. CLIN-r+ highlights the key information that manufacturers need to know.
Article 59 sets out how authorisation of CE Marking requirements derogation for medical devices (not IVDs) can be done. Clin-r+ provides guidance on Article 59 and CE mark derogation.
ISO standards help medical device manufacturers and the medical industry comply with the evolving ‘State of the Art’, international best practices, streamline processes, and improve patient safety and satisfaction. These standards improve risk management and help businesses fulfil legal and industry standards. There are numerous ISO standards in place, and Clin-r+ has constructed this paper to give you an overview of the most common standards for the MedTech industry.
The EU MDR’s regulations on clinical data ensures that the medical device being used on the general public for their treatment or diagnosis is safe. However, there is a category of devices, known as ‘orphan medical devices’, that may suffer if special consideration isn’t provided to it. CLIN-r+ looks at what they are and what this means.
An MDR gap assessment is the process of looking at a medical device’s technical file in a systematic way to determine if it meets all of the relevant MDR requirements. It is the first and most important step in understanding what needs to be done for a device to become MDR compliant. CLIN-r+ shows how a gap assessment can quickly identify important information.
EU MDR requires manufacturers to provide “implant cards” for patients with implanted medical devices. The intention is to make crucial information about implants easily accessible to patients. CLIN-r+ explains what manufacturers are responsible for.
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