Directive NIS2 European Union
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Annex II · sector 16 of 18

NIS2 for Manufacturing


Product security and corporate security collide. The Cyber Resilience Act governs what you ship; NIS2 governs how you run. Teams routinely conflate the two and satisfy neither.

Annex
II
Default class
Important
Supervision
ex post
Maximum fine
7 M€ / 1,4 %

Which entities are covered


Manufacturers of medical devices and in vitro diagnostic medical devices; manufacturers of computer, electronic and optical products; electrical equipment; machinery and equipment n.e.c.; motor vehicles, trailers and semi-trailers; other transport equipment.

Sub-sectors named in the annex

  • Medical devices and in vitro diagnostics
  • Computer, electronic and optical products
  • Electrical equipment
  • Machinery and equipment
  • Motor vehicles, trailers and semi-trailers
  • Other transport equipment

Scope traps specific to this sector


Trap 1

Scope is defined by NACE divisions, so the answer depends on your registered activity code rather than on self-description.

Trap 2

The Cyber Resilience Act (Regulation (EU) 2024/2847) covers products with digital elements. It is a separate obligation from NIS2, not an alternative.

Trap 3

Automotive suppliers face UNECE R155 for vehicle type approval on top of NIS2.

What else applies to you


Cyber Resilience Act; MDR and IVDR; UNECE R155 and R156; the Machinery Regulation.

NIS2 rarely arrives alone. Where another EU act covers the same ground and is at least equivalent in effect, article 4 disapplies the corresponding NIS2 provisions — but only those, and only where that test is met.

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