Are there changes to the procedures for establishing #conformance?

Both the existing and new directives provide for stricter conformance assessment procedures for specific categories of highly hazardous machines listed in Annex IV of the directive. For such machines self-certification is now possible when harmonized standards are fully applied. It will no longer be possible for manufacturers of machines to provide a Technical Construction File to a Notified Body for review and retention. An additional assessment process assuring conformance through inspection and quality assurance is provided.