Integrum’s MDR certification is completed for the OPRA[TM] Implant System
Mölndal, Sweden – December 15, 2023 — Integrum (publ) (Nasdaq First North Growth Market: INTEG B) today announces that the company has received its final MDR certification, thus finalizing the review process of the company’s products under the new EU medical device regulatory (MDR) framework. The company’s OPRATM Implant System product portfolio has thereby been granted MDR certification and may be freely distributed within the EU for treatment in individuals living with disabilities because of limb loss.
Integrum received its MDR certification (Notified Body BSI 2797) for the last reviewed articles of its product portfolio on November 23rd, under MDR 2017/745. The MDR certification granted to Integrum allows CE marking of the devices, meaning that the products fulfill the General Safety and Performance Requirements (GSPR) for and use the company’s medical devices falling under classes IIb, IIa, Is, and Ir.
“This is an important step forward for the regulatory robustness of our innovative products. Further, it is an important milestone for the organization, as we finalize many hours of hard work ensuring compliance to the highest possible product standard, which will serve the patients at the end of the chain,” says Annika Fahlén, Quality Assurance and Regulatory Affairs Director, Integrum.
Based on the certification of Integrum’s entire OPRATM Implant System product portfolio, the company is granted freedom of commercial activity in the EU past the start of the enforcement of the framework in 2024. Thus, the company’s current business development activities will not be hampered due to regulatory thresholds.
“We are pleased to have received our finalized MDR certificates, following a thorough process to ensure the highest regulatory standard for our products. This achievement has been made possible thanks to our dedicated team, and it will play an important role as we continue our expansion on the European market," says Rickard Brånemark, CEO of Integrum.