Compliance

Sector compliance modules — machinery first, medical diagnostics next.

How regulatory conformance shapes what a business may claim and how it should speak — by sector. Regulation exists to take danger out of products; our work is to make compliant market entry achievable and affordable, never to thin its substance.

Three machinery modules are published, with a section-wide help page:

EU compliance for machinery — from first design to end of life — the whole regulatory life of a machine sold into the EU on one page: design and conformity, the two border gates, ten years on the market, substantial modification, end of life.

The documents that govern EU machinery compliance — the reference layer: the law, its guidance, the instruments that travel with a machine, the conditional ones, and the standards — each linked at its official source, with the exact version identifiers we read.

R&D under EU machinery law — where the regulatory frame begins — the boundary of that life: the three events that trigger the law, the R&D corridor of activities it leaves alone, the five surprises at the edge, and the laboratory exclusion.

Where to get official help — the EU's own free practical services (Your Europe, Enterprise Europe Network, Access2Markets, SOLVIT) and the paperwork drawn: the technical file, the Declaration of Conformity, the conformity route.

Medical diagnostics follows.