The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) will create a robust, transparent, and sustainable international regulatory framework to improve the safety of medical devices. The new regulations impact all the stakeholders of the healthcare environment, from the manufacturing industries to doctors, practitioners, and laboratorists that must comply with MDR/IVDR in their daily activities.
All the CE-marked MDs and IVDs will be affected by the new MD and IVD Regulations.
At Copan, we are committed to ensuring our products’ conformity with the EU Regulations to provide the best service to our customers. We have worked relentlessly in the last four years to comply with applicable MDR and IVDR requirements. As a result, our product regulatory compliance and supply reliability are guaranteed, ensuring our trusted partners and clients any product family disruption throughout this transition period.
We completed the transition from IVDD general devices to IVDR CLASS A devices within the date of IVDR application of May 26, 2022, while the certification process for our CLASS A STERILE devices is at an advanced stage and planned to be completed in significant advance before the new deadline of 26 May 2027.
We implemented quality procedures to comply with the EU MDR requirements (e.g., Vigilance and Post-Market Surveillance requirements) that are in force from the MDR application. The certification process for our CLASS IIa devices is at an advanced stage. Our MD CLASS IIa devices will be gradually CE-marked based on a transition plan agreed with the Notified Body TÜV SÜD, and we’ll be able to communicate the CE mark transition to MDR three months before the expected date.
Our Regulatory and Quality departments are committed to giving you the best support in this transition. Do not hesitate to contact us for any need.