State of Play

05 November 2019

Oongoing Impact Assessment on MD vs AI and emerging technologies to be finalised in Q2 2020- ongoing targeted interviews. 

  • Although not officially announced, it is almost certain that the MD will be revised with the objectives of seeking greater legal clarity in scope and definition – revised proposal by end 2020/early 2021:
    • Borderline cases with other directives
    • Definitions to be reviewed for ‘hot’ issues : PCM, specific application and substantial modification
    • Exclusions (machinery on ships and for nuclear purposes)
    • High risk machines Annex IV
  • Address risks pertaining to emerging digital technologies (cybersecurity, transparency of algorithms, software updates)
  • Simplification of administrative burden allowing digital formats for documentation (e.g. manual of instructions)

Preliminary results of opne Public Consultation

  • 528 replies of which 372 from industry, 68 citizens, 35 public authorities, 11 NGOs, 5 trade unions, 4 research institutions and 2 consumer organisations
  • 92% of the respondents form the EU
  • A majority of respondents are in favour of aligning the directive to the New Legislative Framework
  • A majority of respondents would like to review the concept of PCM
  • A majority of authorities, notified bodies and consumer associations see the need for the MD to better cover the safety of human-robot collaboration, machine learning, software updates etc…
  • Opinions are divided about how cybersecurity requirements for manufacturers of machinery should be implemented in the EU
  • Opinions are divided among Member States with regards to digital instructions.