The legal basis for reprocessing under German law (MP Betreiber V) changes on May 26 2021 and will be replaced by medical remanufacturing in accordance with MDR.
There are two options:
1) Medical remanufacturing with CE certification
- Legal basis is Article 17 (2) of the MDR regulation
- All manufacturer obligations of the MDR apply
2) Medical remanufacturing with CS certification
- Legal basis are Article 17 (3) and (4) of the MDR in conjunction with MP Betreiber V Neu (New German Medical Devices Law) and Common Specifications
- Core manufacturer obligations apply
The regulations in the Common Specifications are significantly broader in scope than those previously laid out in the national medical device law governing reprocessing.
Key requirements of the Common Specifications:
- the creation of technical documentation;
- provisions regarding reverse engineering (e.g. construction and materials analysis);
- processes for post market surveillance;
- procedures to identify changes to the design of the original product;
- an extensive system for reporting incidents;
- a product tracing system for each product that allows the identification of the single-use product throughout the reprocessing cycle and the lifetime of the reprocessed single-use device;
- compulsory certification
Details of what these Common Specifications entail can be found >here.