The new MDR compliance challenge
26th May 2021 marks the end of the transition period from the old Medical Device Directive (MDD) to the new Medical Device Regulations (MDR) 2017/745.
From this date, the MDR will be in full effect and EU-based medical device manufacturers will be required to provide updated technical documentation to meet the standards of the new legislative framework.
Across the industry, medical device companies are facing challenges in meeting the demands of the new legislative framework. Long-held claims of equivalence are no longer valid and the need to evidence every indication is placing huge demands on evidence-generation systems that are difficult to meet.
Why has the Medical Device Directive (MDD) been replaced?
Although generally robust and relatively permissive of innovation, the MDD was considered to have numerous flaws in enforcing medical device safety, reliability and general product quality, exposed by notorious incidents such as the metal-on-metal hip scandal. Legislators were compelled to implement reform.
The new MDR attempts to reduce the likelihood of future incidents of this nature by tightening the requirements for proving safety and effectiveness of all medical devices, regardless of how long the product has been on the market.
How will the industry be affected?
From an industry perspective, the most important changes are the need to provide evidence “on an ongoing basis” to support every individual indication, in parallel with the reduced capacity to claim equivalence to devices already approved for sale.
These changes mean that manufacturers across the industry face a significantly increased evidence-generation burden, meaning a potentially huge increase in cost to meet the demands for medical device compliance. In some cases, this may even challenge the commercial viability of a product.
Mantra Systems is the answer to this dilemma. We are experts at navigating the evidence-generation requirements of MDR and will ensure that you have the systems in place to meet the demands of the new legislation.
How can Mantra Systems help you?
Obtaining a medical device CE-Mark under MDR requires robust clinical evidence in the form of Real World Evidence (RWE), built from real world data (RWD). Generating RWE is difficult and resource-intensive. Our experienced specialists will work with you to design and develop your RWE generation system to the highest level of legal and regulatory compliance.
Our MEDDEV 2.12-based systems ensure full harmonization of data collection standards across multiple locations in full adherence to GDPR and all relevant ISO standards.