"In terms of quality and patient safety, we are state-of-the-art!"
Geistlich Pharma obtained the first MDR certificates in August 2021, both for the quality management system and for the first product family, Geistlich Fibro-Gide®. This paves the way for continued market access of all Geistlich Pharma products in the EU. Nicole Guetg, Senior Regulatory Affairs Manager, and Reinhart Seibl, Director Regulatory Affairs, discuss the background.
What do the MDR certificates stand for?
Reinhart Seibl (RS): For me, the certificates are a sign of our shared values and goals. It is also a pioneering achievement by Geistlich Pharma, as we were among the first companies to obtain MDR approval in our product category.
Nicole Guetg (NG): There were many challenges in implementing the MDR requirements. The certificates confirm the approach how Geistlich Pharma tackled this complex task and completed the implementation successfully, and in an interdisciplinary, team oriented and straightforward manner.
What does all this mean for customers and users of the products?
RS: On the one hand, as a customer I have the certainty that the proven products from Geistlich Pharma will continue to be available on the EU market. On the other hand, the MDR certificates also show me that Geistlich Pharma is state-of-the-art in terms of quality and patient safety. The safety and quality of proven products has been confirmed under highest requirements.
NG: Geistlich Pharma has always attached great importance to profound scientific and clinical evidence of the safety and efficacy of its products. As a result, the more stringent regulatory requirements could be met without any problems, which confirms to me as a customer that Geistlich Pharma products meet the highest level of quality.
What do the new regulations bring in terms of transparency?
RS: The newly created EU database (EUDAMED) gives customers and patients access to medical device information on safety and performance, clinical studies, vigilance data and scientific opinions from expert panels as part of the market authorization process. The increased transparency as part of improved market surveillance is in the service of increased patient safety. We welcome and support this approach.
Which additional quality and process requirements due to the MDR does Geistlich Pharma fulfil?
NG: As part of the MDR implementation at Geistlich Pharma, we have expanded various existing processes, e.g. we issue a periodic safety update report. Further, we have established new processes, e.g. the Unique Device Identifier (UDI) code and the Patient Implant Card ensure better traceability. As already mentioned, physicians and patients benefit from increased transparency based on a newly created summary on safety and clinical performance.
Can you outline the next steps regarding the topic of MDR certification?
NG: Now, we have certified the quality management system and the first product family, Geistlich Fibro-Gide®, according to MDR. The approvals of the remaining product families in accordance with the MDR will follow in the next two and a half years. Our plan for this is in place, all the steps have been defined.
RS: A MDR product certificate is valid for five years. For successful renewal, the complete technical documentation of the product will be reassessed, and in parallel, our quality management system is audited annually by the Notified Body.
NG: We continue to be very well positioned and fit for upcoming challenges!
RS: I can only confirm that.