Regulation 4 Notification of conformity assessment bodies
For the purposes of Article 20 of Regulation 2019/1009, the notifying authority must notify to the European Commission and EU member States only those conformity assessment bodies that qualify for notification.
To qualify for notification a conformity assessment body must submit an application for notification to the notifying authority in accordance with Article 27 of Regulation 2019/1009.
For the purpose of deciding whether to notify a conformity assessment body the notifying authority may have regard to any other matter that appears to the notifying authority to be relevant.
Where the notifying authority notifies a conformity assessment body, the notifying authority may set conditions that the conformity assessment body must meet including any conditions that are to apply upon or following the restriction, suspension or withdrawal of its status as a notified body.
Subject to paragraph (6), if at any time it appears to the notifying authority —
that a notified body no longer meets the requirements laid down in Article 24 of Regulation 2019/1009; or
that it is failing to meet its obligations,
the notifying authority may by written notice to that body specify a date on which its status as a notified body will be restricted, suspended or withdrawn, as appropriate depending on the seriousness of the failure to meet those requirements or obligations.
Before the notifying authority restricts, suspends or withdraws the status of a conformity assessment body as a notified body under paragraph (5) the notifying authority must—
give notice in writing to the notified body of the action which the notifying authority intends to take;
give the notified body the opportunity to make representations within a reasonable period from the date of that notice; and
consider any representation made within that period by the notified body before making a decision on whether to take such action.
Where the notifying authority has taken action in respect of a notified body under paragraph (5), or where a notified body has ceased its activity as a conformity assessment body, the body must—
on the request of the notifying authority, transfer its files relating to the activities it has undertaken as a notified body to another notified body or to the notifying authority;
in the absence of a request under sub-paragraph (a), ensure that any document it holds relating to the activities it has undertaken as a notified body is kept available for the notifying authority for a period of 10 years beginning on the day on which the relevant document was created.