MDR – Article 46 – Changes to designations and notifications

Article 46

Changes to designations and notifications

1. The authority responsible for notified bodies shall notify the Commission and the other Member States of any relevant changes to the designation of a notified body.

The procedures described in Article 39 and in Article 42 shall apply to extensions of the scope of the designation.

For changes to the designation other than extensions of its scope, the procedures laid down in the following paragraphs shall apply.

2. The Commission shall immediately publish the amended notification in NANDO. The Commission shall immediately enter information on the changes to the designation of the notified body in the electronic system referred to in Article 57.

3. Where a notified body decides to cease its conformity assessment activities it shall inform the authority responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine months after cessation of the notified body’s activities on condition that another notified body has confirmed in writing that it will assume responsibilities for the devices covered by those certificates. The new notified body shall complete a full assessment of the devices affected by the end of that period before issuing new certificates for those devices. Where the notified body has ceased its activity, the authority responsible for notified bodies shall withdraw the designation.

4. Where a authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has not implemented the necessary corrective measures, the authority shall suspend, restrict, or fully or partially withdraw the designation, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same period.

The authority responsible for notified bodies shall immediately inform the Commission and the other Member States of any suspension, restriction or withdrawal of a designation.

5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the manufacturers concerned at the latest within 10 days.

6. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall take appropriate steps to ensure that the files of the notified body concerned are kept and make them available to authorities in other Member States responsible for notified bodies and to authorities responsible for market surveillance at their request.

7. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall:

(a)assess the impact on the certificates issued by the notified body;
(b)submit a report on its findings to the Commission and the other
Member States within three months of having notified the changes
to the designation;
(c)require the notified body to suspend or withdraw, within a
reasonable period of time determined by the authority, any
certificates which were unduly issued to ensure the safety of devices on the market;
(d)enter into the electronic system referred to in Article 57 information in relation to certificates of which it has required their suspension
or withdrawal;
(e)inform the competent authority for medical devices of the Member State in which the manufacturer has its registered place of businessthrough the electronic system referred to in Article 57 of the
certificates for which it has required suspension or withdrawal. That competent authority shall take the appropriate measures, where
necessary to avoid a potential risk to the health or safety of patients,users or others.

8. With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in the following circumstances:

(a)the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction, that there is no safety
issue in relation to certificates affected by the suspension or
restriction, and the authority responsible for notified bodies has
outlined a timeline and actions anticipated to remedy the
suspension or restriction; or
(b)the authority responsible for notified bodies has confirmed that no
certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to
monitor and remain responsible for existing certificates issued for
the period of the suspension or restriction. In the event that the
authority responsible for notified bodies determines that the
notified body does not have the capability to support existing
certificates issued, the manufacturer shall provide, to the competent authority for medical devices of the Member State in which the
manufacturer of the device covered by the certificate has its
registered place of business, within three months of the suspension or restriction, a written confirmation that another qualified notified body is temporarily assuming the functions of the notified body to
monitor and remain responsible for the certificates during the
period of suspension or restriction.

9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months in the following circumstances:

(a)where the competent authority for medical devices of the Member
State in which the manufacturer of the device covered by the
certificate has its registered place of business has confirmed that
there is no safety issue associated with the devices in question; and
(b)another notified body has confirmed in writing that it will assume
immediate responsibilities for those devices and will have
completed assessment of them within twelve months of the
withdrawal of the designation.

In the circumstances referred to in the first subparagraph, the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its place of business may extend the provisional validity of the certificates for further periods of three months, which altogether shall not exceed twelve months.

The authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.

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