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Requirements for a PIM system: Medical technology

The EU Medical Device Regulation (MDR) has presented manufacturers with new documentation and traceability requirements since 2021. Centralized, digital management of product information with an efficient PIM system will therefore become a key task in medical technology.

Illustration of a medical scene: A patient sits on a hospital bed with her arm bandaged and looks to the right at a doctor in scrubs. He is carrying a tray with utensils. To his right is a medical trolley with equipment. The scene symbolizes the medical technology industry.

When EU Regulation 2017/745 (Medical Device Regulation - MDR) came into force, the regulatory landscape for manufacturers of medical devices changed significantly. The requirements for product documentation have been tightened - including classification rules, technical specifications, conformity assessments, clinical data and information on traceability and accessories. The archiving period has also been extended from five to ten years. These requirements make structured, digitally accessible and versionable product data management indispensable. In particular, the traceability of historical changes and the link to post-market data can be efficiently mapped with a central system. Against this background, crossbase is positioning itself specifically as a solution partner for the medical technology industry.

Key benefits for your industry

Management of registration data such as registration number etc.
Evaluation of registrations per article and destination country
Management and description of medical devices
Management of medical-specific documents, images and films
Management of symbols, trade names and documents
Management of patents, standards and their metadata
Archiving/traceability of all published web and print content