Ortho Europe MDR Statement – April 2021
Ortho Europe is committed to fulfilling all its regulatory requirements and as we approach the May 26th 2021 deadline for all medical devices sold into the EU to be compliant with the new Medical Device Regulations – MDR (EU) 2017/745. We would like to provide an update on our regulatory position.
Ortho Europe is a long-established manufacturer and distributor of class 1 medical devices to support patients in the field of prosthetics, orthotics, and specialist seating. We have established distribution partnerships with some of the leading suppliers in our field and our production facilities use world-class technology to manufacture bespoke devices which match the user’s requirements exactly.
As a business we operate in accordance with ISO Standard 13485 for medical devices and we hold ourselves accountable to these rigorous standards to ensure we provide only the very best quality products. To help ensure this we have a dedicated Quality and Regulatory Affairs function, and a Quality Management System (QMS), which we regularly review and evolve to meet our changing business and regulatory obligations.
MDR is a significant development, which we welcome, as it will strengthen the existing regulatory system for medical devices in Europe by replacing the original directives which have been in place for over 25 years. Above all else though, it puts the patient’s safety first, which is one of our guiding values.
In preparation for MDR we firstly set up several internal workstreams to audit our manufactured products and our suppliers, and secondly, we have commenced phasing in MDR compliance across applicable product families to ensure we meet out compliance obligations by the May 26th deadline, including the following:
• The instructions for use (IFU) and labelling on all Ortho Europe manufactured and distributed items is fully compliant with the requirements of MDR.
• EU declarations of conformity (DoCs) for all Ortho Europe manufactured and distributed items are available on request.
Ortho Europe will continue to do what is required to ensure we are in a state of MDR readiness by the required deadline.
This statement will be updated as and when new information becomes available but if you require any further information on our regulatory position, please do not hesitate to contact us via MDR@ortho-europe.com