Article 36 — Changes to Notifications

WHAT THE ARTICLE IS ABOUT

Managing changes to notified body designations over time

Article 36 establishes the procedures for updating, restricting, suspending, or withdrawing notified body designations after they have been granted. It ensures that the notified body system remains accurate and trustworthy over time — that bodies which cease to meet the requirements lose their designation, and that providers relying on existing certificates are protected during transition periods.

WHAT IT SAYS

Notifying authorities can restrict, suspend or withdraw — with transitional protections

• Notifying authorities must continuously monitor their designated notified bodies to ensure they continue to meet the Article 31 requirements
• Where a notified body no longer meets requirements or fails to fulfil its obligations, the notifying authority must restrict, suspend or withdraw the designation as appropriate
• The notifying authority must inform the Commission and other member states immediately of any restriction, suspension or withdrawal
• Where a designation is withdrawn or restricted, the notified body must inform affected providers — particularly those with ongoing assessments or recently issued certificates
• Certificates already issued by a suspended or withdrawn notified body remain valid for a transitional period, unless they have been specifically invalidated
• Another notified body may take over ongoing assessments where a body has been suspended or withdrawn, subject to agreement with the provider

WHO IS AFFECTED

Notified bodies, their notifying authorities, and providers holding certificates

• Notified bodies whose designation status changes — whether through their own request or regulatory action
• Providers who have received certificates from a body that is subsequently suspended or withdrawn
• Providers with ongoing assessments at the time of a suspension or withdrawal
• Notifying authorities responsible for monitoring and acting on compliance failures
• The Commission and other member states who must be informed of changes

WHAT IT MEANS FOR SMES

Monitor the status of your notified body after certification

• A certificate issued to you by a notified body does not automatically become invalid if that body is later suspended — but check the NANDO register periodically to confirm your certifying body’s status remains active
• If your notified body is suspended or withdrawn while your assessment is ongoing, you are entitled to have the assessment transferred to another notified body — this should be at no additional cost attributable to the body’s failure
• Build a check of your notified body’s NANDO status into your annual compliance review — do not assume it will remain active indefinitely
• If you receive notification from your notified body that their designation has changed, seek legal advice immediately on the implications for your certificates and market authorisation
• The transitional validity of certificates provides some protection — but acting quickly when a body’s status changes is important to avoid gaps in compliance

Related Articles

• Article 35 — NANDO register (where status changes are reflected publicly)
• Article 37 — Challenge to competence (the investigation that may precede a suspension or withdrawal)
• Article 44 — Certificates (the validity of certificates issued by a body subsequently withdrawn)
• Article 31 — Requirements for notified bodies (the standards continuous monitoring checks against)