The CE Machinery Directive is primarily a “self-certification” directive. However, if your product is one of the high risk products listed in Annex IV of the Machinery Directive, self-certification may not be permitted in which case a Notified Body must be involved.

Notified Body Involvement: In Article 12 of the Machinery Directive, the procedures for assessing that a product complies with the Directive are specified. If the product is a high risk machine as identified in Annex IV, most of the procedures for confirming compliance specify that a “Notified Body” is required to verify that the product meets all applicable CE-MD requirements and to also conduct a Quality review.

‍CE-MD Annex IV Products: The products listed in Annex IV of the CE-MD as high risk are as follows:

1. Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:

  • Sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or carriage;
  • Sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading;
  • Sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual loading and/or unloading.

2. Hand-fed surface planing machinery for woodworking.

3. Thicknessers for one-side dressing having a built-in mechanical feed device, with manual loading and/or unloading for woodworking.

4. Band-saws with manual loading and/or unloading for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:

  • ‍Sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement bed or support for the workpiece;
  • Sawing machinery with blade(s) assembled on a carriage with reciprocating motion.

5. Combined machinery of the types referred to in points 1 to 4 and in point 7 for working with wood and material with similar physical characteristics.

6. Hand-fed tenoning machinery with several tool holders for woodworking.

7. Hand-fed vertical spindle molding machinery for working with wood and material with similar physical characteristics.

8. Portable chainsaws for woodworking.

9. Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.

10. Injection or compression plastics-molding machinery with manual loading or unloading.

11. Injection or compression rubber-molding machinery with manual loading or unloading.

12. Machinery for underground working of the following types:

  • ‍Locomotives and brake-vans;
  • Hydraulic-powered roof supports.
  • Manually loaded trucks for the collection of household refuse incorporating a compression mechanism.

13. Removable mechanical transmission devices including their guards.

14. Guards for removable mechanical transmission devices.

15. Vehicle servicing lifts.

16. Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than three meters.

17. Portable cartridge-operated fixing and other impact machinery.

18. Protective devices designed to detect the presence of persons.

19. Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11.

20.Logic units to ensure safety functions.

21. Roll-over protective structures (ROPS).

22. Falling-object protective structures (FOPS).

CE-MD Path to Compliance: For products falling under Annex IV, the product manufacturer must choose one the compliance paths defined in Article 12, part 3 and 4, of the CE-MD. Note that all of these options require the involvement of a Notified Body except Article 12, Part 3, option “a”.

1) Article 12, Part 3: This article applies to Annex IV products that meet all relevant standards listed under the Machinery Directive and, there no other standards identified as the means to address any of the Essential Health & Safety Requirements (EHSR’s) in your Annex I report.

  • Assessment of conformity with internal checks on the machinery per Annex VIII or,
  • EC Type examination per Annex IV plus internal checks on the manufacture of machinery per Annex VIII, item 3 or,
  • Full Quality review per Annex X

2) Article 12, Part 3: A reduced set of options is offered to Annex IV products who either do not meet all applicable standards listed under the Machinery Directive or, that use other standards to address any EHSR’s in your Annex I report.

  • EC Type examination per Annex IV plus internal checks on the manufacture of machinery per Annex VIII, item 3 or,
  • Full Quality review per Annex X

Annex IV – Avoiding the Notified Body: Using a Notified Body can add considerable time and cost to the CE compliance process. Perhaps a bigger consideration is that the Notified Body takes the final decision process away from the manufacturer.

The only path to CE Machinery Directive compliance for Annex IV products that does not mandate use of a Notified Body is Article 12, Part 3, option “a”. With this option, the manufacturer is responsible for verifying compliance, creating and maintaining the Technical Construction File, and insuring manufacturing quality. Of course there may be times when use of a Notified Body is beneficial – to make difficult technical decisions and perhaps reduce manufacturer risk for very high risk products. And if you make an Annex IV type of product and you wish to use ASTM or other standards not listed under the Machinery Directive instead of the EN standards, you must use a Notified Body.

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