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
On September 11, 2025, the Federal Ministry of Justice (BMJV) published a draft bill to reform product liability law.
Suppliers beware. According to the ECJ, a (quasi-)manufacturer is not only someone who produces a product, but also someone who sells it under the same name and logo as the manufacturer.
Product safety is a valuable asset, especially when modern technology is involved.
The new EU Product Liability Directive was published in the EU Official Journal on 18.11.2024, enters into force on the twentieth day after its publication and must be transposed into national law by 09.12.2026.
