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All medical devices placed on the EU marketplace after May 2021 will need to be compliant to the Medical Device Regulations (MDR) or the In Vitro Diagnostics Regulations (IVDR). Compliance with the Medical Device Directives will no longer be acceptable.
Risk Management is the underlying foundation that helps businesses quantify medical device risks that could impact the patient or medical team. It is a critical part of the medical device product development process.
All medical device manufacturers or ‘virtual manufacturers’ (Own Brand Labelling) are now required, under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), to have a Quality Management System in place.
Medical Device Manufacturers that do not have a registered company address in the UK after Brexit will not be able to sell their products on the UK market unless they have an Authorised Quality Management Representative registered in the UK.
The Medical Device Regulations (MDR) or the In Vitro Diagnostics Regulations (IVDR) now include regulation on manufacturers having a Person Responsible for Regulatory Affairs.
If you do not have a quality management system in place, to help with your ISO 13485 implementation our consultants are here to help.
Biological Evaluation is a very important part of your validation requirement for your medical device, make sure you get the right advice.
Clinical evidence has become much more important as part of the new regulations. It’s important that medical device manufacturers provide sufficient information to demonstrate that their devices are clinically safe.
As part of ISO 13485 Quality Management Systems, it is a requirement for all internal audits to be performed on the systems processes and procedures, ensuring that the necessary standards are met. Any issues that arise should be corrected and actioned.
Many manufacturers of medical devices have subcontractors who perform critical parts of the device manufacturing or development process. These suppliers must be correctly managed to ensure that the quality of the device being developed or manufactured does not suffer, and complies with the agreements that the companies have in place.
As of June 2023 all medical device manufacturers will need to place the UKCA mark on medical devices sold on the UK market place.
As of 1st January 2021 Brexit regulation now include regulation on medical device manufacturers based outside of the UK who place device on the UK market having a UK Responsible Person (UK Authorised Representative).
We have now opened an office in Germany and provide an EU Authorised Representative Service.