Which regulatory areas are affected?
Among others, these areas are affected:
- Classification rules: The rules have been extended to include Class Ir (reusable surgically invasive instruments). The requirements related to implantable products of Class llb have increased. New risk classes have been introduced for several product categories, which potentially entails products being up-classified.
- Clinical evidence: In the future, all medical devices are subject to a clinical evaluation obligation regardless of the class.
- Scrutiny procedures (consultation procedure): New implantable Class III devices and Class llb active devices which administer and /or remove medicinals are to be more strictly controlled before market entry.
- Notified bodies: The requirements placed on the notified bodies are increasing. At the same time, they will in the future be obliged to perform unannounced audits at manufacturers.
- Technical documentation: Documentation due to the MDR increases significantly the effort for manufacturers.
- EUDAMED: An electronic database for monitoring the product lifecycle has been introduced.
What kinds of challenges exist?
In order to be able to ensure continuous supply with safe and innovative medical technology, all manufacturers are faced with the challenging task of overcoming the increased requirements necessary to receive the CE mark. The notified bodies must lay the foundation and create sufficient capacity for the conformity assessment procedure.
At an earlier point in time, B. Braun already began wide-ranging preparations for the certification of its own medical devices in accordance with the MDR. Naturally, this applies to all products that B. Braun manufactures itself or purchases as commercial goods to complete its portfolio. With regard to the progress of the measures taken, B. Braun is confident it will be able to comply with the requirements of the MDR until May 2024.