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
The EU internal market for products is regulated by the NLF and its 30 harmonised legal acts. The European Commission is currently planning to revise the NLF. For this to be successful, the focus must be on simplification.
The EU Commission is planning a comprehensive reform of key aspects of product law: digitalization of the New Legislative Framework, strengthening of market surveillance and accelerated standardization are intended to increase competitiveness and product safety.
Consultation on Regulation (EU) No. 1025/2012: VDMA advocates optimized standardization processes to ensure the efficiency and competitiveness of European industry and to meet modern market requirements
On July 19, 2016, the Pressure Equipment Directive 97/23/EC was bindingly replaced by the "new" Pressure Equipment Directive 2014/68/EU, adapted to the new European legal framework. The interpretation of the newly introduced terms "risk assessment" and "risk analysis" has repeatedly given rise to discussions in practice.
