Our team BLOGGER this month is our very own Mike Bowles, Operations Director who has his finger on the pulse of regulatory matters.
Read his update here:
Regulatory update at EMS Physio – March 2021
EMS Physio supplies medical devices to assist Physiotherapists to relieve pain and improve the quality of life of their patients.
As a manufacturer of class IIa and IIb medical devices, EMS Physio is required to meet particular regulatory requirements in order to place these devices on the market.
These regulatory requirements comprise of 2 key areas –
Firstly – we must maintain an ISO 13485 Quality Management System that documents every aspect of our business, including product design, selection and approval of suppliers, procurement of materials, manufacture and test and of course sales and contract review.
Secondly – the devices that EMS manufactures are required to have a CE mark to show conformance with the Medical Devices Directive. For each device, we must maintain a technical file that contains all information relevant to the safety and effectiveness of that device. This includes clinical evaluation, biocompatibility assessment and safety test reports.
The CE mark may only be applied to our devices when a third party Notified Body has reviewed our management systems and approved the content of the technical file for each product. We are subjected to annual audits by our Notified Body – these are pre-planned and last anything from 8 to 12 days. Additionally, our Notified Body also carries out “unannounced inspections” periodically, to make sure that we continue to follow correct procedures at all times.
Without a CE mark we cannot supply our products within Europe or the UK. Recent changes as a result of the UK leaving the EU have complicated this somewhat and there are fresh challenges ahead – more of that another time. Requirements for shipping our products globally often start with a CE mark and then a list of additional regional requirements are added. In an attempt to simplify these often complex, global regulatory requirements, a new audit option is now available. This new audit option is called the Medical Devices Single Audit Programme (MDSAP). This includes the familiar ISO 13485 requirements but also the additional requirements for the USA, Canada, Brasil, Australia and Japan – as applicable.
EMS Physio decided to take the MDSAP option to protect our ability to supply our global market. We recently had our MDSAP Notified Body audit, and I am delighted (and a little relieved) to report that after a total of 12 days of scrutiny we were found to have only 4 minor non-conformances across the whole of our organisation. This is thanks to the efforts of the staff involved during the audit but also to all staff who take great care and attention (365 days of the year) to ensure that the correct, approved processes and procedures are followed – resulting in clear records and an audit trail that can be used to demonstrate compliance.
But also, and most importantly – we can be confident that our products are safe and effective, and our hard-earned CE mark is something we are all very proud of because we know we are supplying a high-quality product that is helping our customers to relieve pain and improve the quality of life of their patients.
Written by Mike Bowles