The compliance deadline for the new EU MDR is right around the corner. With new regulations come new processes affecting medical device companies. Time is of the essence with nearly one month remaining, and manufacturers still have much to consider before the deadline. But which of the changes under EU MDR are impacting companies the most? And what is the best way to respond?
Total Lifecycle Traceability
While companies have previously been encouraged to achieve traceability throughout a device’s total lifecycle, EU MDR now mandates it. According to the new regulation, medical device manufacturers must be able to demonstrate traceability from product development through post-market analysis.
In a recent report on 2021 EU MDR readiness, we found only one of four companies feel “very confident” their traceability capabilities could withstand an audit. By May 26, 2021, companies will need to better grasp how to merge new and existing data so that systems can adequately capture the right information to fulfill EU MDR requirements.
A purpose-built quality management system (QMS) can help companies demonstrate total lifecycle traceability by automating the infusion of post-market quality data into design activities. Freed from an inefficient, error-prone process, teams can then spend their time on activities that better support company growth.
Since incorporating post-market data into quality management systems is now required under the new medical device regulation, companies will have to be savvier about capturing that intelligence. Specifically, EU MDR focuses on revised reporting requirements based on post-market surveillance.
Manufacturers with low-risk Class I devices must deliver a post-market surveillance report (PMSR) summarizing the results and conclusions of their data, according to the new requirements. They’ll also have to include details and rationale for corrective actions taken.
The new requirements also specify updated timeframes based on the type of information reported:
- Serious threats to public health: 2 days
- Death or serious health deterioration: 10 days
- All other serious incidents: 15 days
Much like traceability, post-market surveillance requires a QMS to efficiently connect key processes throughout the total product lifecycle.
To more easily capture and process relevant incident data, companies will need a reliable QMS that’s built to function in such a way. A system built for medical devices will sport the infrastructure to develop ongoing reports in line with these new parameters.
EU MDR invited a major overhaul of medical device labeling requirements. Alongside the usual requirements, the new EU regulation includes required steps for developing a general safety and performance requirements (GSPR) checklist.
A device label must include warnings, precautions or contraindications—and a summary of safety and clinical performance for Class III and implantable devices. Labels will also need to carry the EC representative’s name, address, and symbol along with a new symbol indicating the product is a medical device. Labels must be printed and published on the manufacturer’s website, accompanied by user data.
While not an immediate concern, companies must also establish a procedure to upload their Unique Device Identification (UDI) information into the EUDAMED database. Manufacturers have until May 2022 to do so.
Every medical device must be accompanied by clinical evidence as stipulated in EU MDR. Depending on the device class, this could mean extensive clinical testing will need to be conducted. This new requirement will have the biggest impact on manufacturers selling older devices without readily available evidence. In addition, manufacturers with broad device portfolios will likely bear the largest cost burden to complete necessary clinical tests.
Start planning your clinical testing as soon as possible, if applicable, as it’s a costly and time-intensive process. Companies concerned about the feasibility of testing certain products may need to remove such products from the EU market. It’s worth employing a cost-benefit analysis, paying particular attention to low-sale products or ones where the costs of testing exceed returns from the marketplace.
Part of EU MDR’s increased emphasis on traceability means compliance with these requirements extends to every third-party supplier and manufacturer involved at any stage throughout the product lifecycle. For this reason, it’s important for manufacturers to understand how all Economic Operators (as the regulations call them) involved are meeting compliance standards, too.
May 26, 2021 will be here soon, and medical device companies still have much to prepare ahead of time. Those concerned about complying with EU MDR, however, should start by addressing the aforementioned key changes. By researching the regulations and understanding how a purpose-built QMS can help fill system gaps, companies can meet these requirements head-on.