On 21 May 2024, the MHRA published a Statement of policy intent: international recognition of medical devices update. This exciting development means that MHRA will start accepting medical devices that already meet EU, USA, Australian, and Canadian regulations with conditions. CLIN-r+ explains the succession of events that has brought us to this point and what the future holds for manufacturers entering the UK market.
Before CE registration, medical device classification is crucial. Classification affects the device’s regulatory requirements, approval route, and expenditures. Manufacturers are responsible for the correct classification of their device(s). CLIN-r+ has created this paper to give an overview of the process.
Do manufacturers need to conduct investigations or follow an exemption route? CLIN-r+ explores the exceptions as outlined by MDCG 2023 and MDCG 2020-6.
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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