We are pleased to announce that our portfolio of reusable surgical instruments is now certified under the EU Medical Device Regulation (MDR 2017/745), CE marked, and produced under a certified ISO 13485 quality system.
The MDR is the European Union’s current medical device regulation, replacing the former MDD (Medical Device Directive). It sets stricter requirements for clinical evaluation, traceability, and post-market surveillance, with the goal of improving patient safety and product transparency.
As a Norwegian manufacturer, we take full responsibility for regulatory and quality processes. Compliance is integrated into how we work, from internal procedures to documentation and final delivery.
This certification reflects the high standards we hold ourselves to at Aprikos Medical. We want our partners to know they can trust our instruments in every procedure, because safety and compliance are built into everything we do. Our conformity has been independently verified, giving our customers confidence that we meet the strictest regulatory demands.
What this means for hospitals, clinics, and procurement teams
Choosing an MDR-compliant supplier is no longer optional. With regulatory enforcement increasing across Europe and beyond, the burden of compliance is shifting to buyers. Many tenders now require complete technical documentation, proof of CE marking, and verified conformity under MDR.
Our MDR certification process included the full involvement of a Notified Body. This means our technical documentation, quality system, and product conformity have all been independently reviewed and approved by a designated European conformity assessment authority.
This provides buyers with an added layer of assurance:
- Independent third-party verification of safety and performance
- Conformity assessment aligned with the highest European regulatory standards
- Reduced liability and audit risk for procurement teams
By working with Aprikos Medical, stakeholders gain:
- Verified regulatory compliance with MDR, CE mark, and ISO 13485
- Complete documentation ready for audits, submissions, and onboarding
- Reduced supply risk with full manufacturer accountability
Our compliance helps you stay compliant.
For procurement teams and distributors looking ahead
We understand what regulators ask for. We understand what hospitals expect. And we’ve structured our operations to meet those expectations now and going forward.
If you’re evaluating surgical instrument suppliers and need a reliable partner with full MDR certification, CE marking, and ISO 13485 documentation, we are ready to support you.
