Level 2 minimal - vdma.eu
The HAS-System (Harmonised Standards Assessment System) forms the basis for the European Commission to confirm the suitability of a Harmonised Standard for presumption of conformity. Unfortunately, the system has weaknesses and requires corrections.
Since 2017, the European Commission has anchored Common Specifications as an alternative to harmonised standards for presumption of conformity in the Medical Devices Regulation. Now, it is applying this instrument across the board
Some machines and systems have to meet extensive safety requirements, including a revised standard. Here, over-engineering must be avoided, as must the risk of incomplete implementation of the requirements. What helps!
Mode of Operation Maintenance (MO MT) – Safety Requirements for an additional Mode of Operation
