News update regarding MDR ROI and NI customers: upcoming changes to the laws around the issuing of medical devices. These will affect many healthcare professionals, including podiatrists, who work in Northern Ireland and any EU member country.
As the 26th of May 2021 approaches, we have worked on developing and implementing strategies to achieve compliance with the new European Medical Device Regulation MDR 2017/745 and UK MDR 2002. Firefly has engaged with a third-party regulatory consultant and have carried out a regulatory assessment of the requirements of the MDR 2017/745 for Class I Custom-Made Devices.
MDR compliance means that as custom-made medical device manufacturers we need to comply with the EU Medical Device Regulation (MDR) in order to sell within the EU market and Northern Ireland. For Great Britain (England, Wales, Scotland), The EU Medical Device Directive MDD 93/42EEC is transposed into UK law through the Medical Devices Regulations 2002 (UK MDR 2002).
Firefly was awarded EN ISO 9001:2015 by the NSAI in 2018 and have taken the necessary steps to integrate the new MDR compliance into our current Quality Management System (QMS) by developing a Regulatory Strategy that ensures we meet the general safety and performance requirements. This award recognises Firefly’s excellence in quality management systems. For our clients, this means you can have confidence that Firefly’s procedures, products and services meet the highest international standards.
We can confirm the following will be implemented:
- Generating and Maintaining Technical Documentation (MDR 2017/745 Annex XIII Section 2)
- Preparing Instructions for Use and Labelling
- Providing a Statement that the device conforms to the general safety and performance requirements (MDR 2017/745 – Annex XIII – Section 1)
- Registering with Competent Authority (HPRA / MHRA)
- Post Market Surveillance system
- Appointment of a Person Responsible for Regulatory Compliance
From 26th May 2021, Firefly Orthoses customers will receive a ‘custom made statement’ to be presented to the patient along with each custom-made and modified device dispatched from Firefly.
We would suggest that as a prescribing clinician, you refer to the College of Podiatry for guidance and training on the regulations and what is required in your clinical setting. To comply with the regulations, standards of quality and performance need to be recorded and reported. This requires you to provide certain information to your patients as well as documenting details of the product you have issued/prescribed to the patient in your clinic notes.
If you require any further information regarding same, please do not hesitate to contact us.