At Aabentoft, we view MDR as an ongoing process that we prioritize highly in our daily work. We also see it as an area that requires collaboration between medical device manufacturers, therapists/appropriate authorities, and ourselves as a technical service partner in the process.
Medical Devices, Class 1
Class 1 medical devices refer to low-risk equipment, meaning they have low complexity and low risk, according to the Medical Device Regulation (MDR). Class 1 devices must meet MDR requirements regarding quality, safety, and documentation. The goal is to ensure that even low-risk products meet high standards for patient safety and product quality in accordance with European legislation.
Custom Made Devices
At Aabentoft, we work with Custom Made Devices in relation to Class 1 medical devices, in accordance with the Medical Device Regulation (MDR). This refers to medical devices that are specially designed or adapted to meet an individual patient’s specific needs or the specifications of healthcare professionals. These are not standardized products; they are made to directly match the unique requirements and characteristics of a specific patient.
Class 1 medical devices are low-risk and low-complexity. Under MDR, manufacturers must comply with certain rules and standards for design, production, and documentation. At Aabentoft, we collaborate with individual therapists/appropriate authorities and manufacturers throughout the entire process.
Aabentoft carries out all adjustments solely based on a work description from either the ordering therapist/appropriate authority and/or the manufacturer of the Class 1 medical device.
Aabentoft documents the technical aspects of the customization process to ensure traceability, transparency, and subsequent monitoring of the medical device. The therapist/appropriate authority is responsible for the requisition/work description and the clinical evaluation based on their professional expertise.
Requisition from Authority
For customizations and special constructions of Class 1 medical devices, we confirm that any modifications are made solely based on a formal requisition from the relevant authority or manufacturer of the specific Class 1 medical device. This ensures that adjustments are made in accordance with the specifications and requirements of authorized entities and manufacturers, maintaining the highest level of safety and efficacy for the medical devices. Our dedication to compliance and collaboration with relevant parties is crucial for ensuring optimal functionality and adherence to all applicable standards.
Registered with the Danish Medicines Agency
Aabentoft is registered with the Danish Medicines Agency under several roles, including:
- Manufacturer of custom-made medical devices – Class 1
- Distributor of custom-made medical devices – Class 1
- Importer of custom-made medical devices – Class 1
- Authorized representative
Registered with EUDAMED
Aabentoft is registered with EUDAMED under several roles, including:
- Manufacturer of custom-made medical devices – Class 1
- Importer of custom-made medical devices – Class 1
- Authorized representative
If you have any questions, please contact Per Aabentoft or Marlene Rasmussen at 00 (45) 86 97 53 00.