Let’s start with a definition, Medical device’ means ‘any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings.’ Examples of medical devices may include dental or surgical instruments, bandages or even hospital beds.
VDR (In Vitro Diagnostic Medical Device) has a different meaning and hence definition but we’ll leave that for another day and another discussion.
ISO 13485 specifies the requirements for a Medical Device Quality Management System – Requirements for Regulatory Purposes, so from the off, that reference to regulation is embedded within the standard. Most of us know that in this area of operation the regulator is the MHRA (Medicines and Healthcare Products Regulatory Agency) and that key legislation includes the MDR or Medical Device Regulations 2002. The MDR legislation is of course derived from the original EU Medical Device Regulations and post Brexit there are a number of nuances that may apply when placing a device on the Great Britain market (Northern Ireland Regs are slightly different) and organisations selling or distributing medical devices in the UK must have a UK based UKRP. QCS International have a well-established UKRP (United Kingdom Responsible Person) service for those organisations requiring guidance and support in this area. The key responsibilities of a UKRP include ensuring regulatory compliance of medical devices, keeping technical documentation accessible to the MHRA for inspection, facilitating communication between the MHRA and the manufacturer and reporting complaints or feedback from healthcare professionals, patients and users to the manufacturer.
So, back to routes to market, how do we begin marketing and selling our medical device in Great Britain? One of the first tasks is to determine the risk associated with the device which will identify the medical device class and in turn determine whether assessment is required by a notified body. For medical devices there are four risk classification groups:
- Class III – includes pacemakers and heart valves (highest risk)
- Class IIb – includes lung ventilators and bone fixation plates
- Class IIa – includes dental fillings and surgical clamps
- Class I – includes wheelchairs, stethoscopes and spectacles (lowest risk)
For further information on our UKRP service and how we support medical device manufacturers placing devices on the UK market or ISO 13485 Medical Device QMS Auditor training reach out to our friendly team of advisors who will welcome your enquiry and be pleased to offer assistance.