EU Technical Documentation Assessment Certificate
The Notified Bodies follow chapter II of Annex IX in MDR for the conformity assessment of the technical documentation of the medical device manufacturers and issue EU Technical Documentation Assessment Certificate on conformance to all the obligations of the MDR. The technical documentation should contain the information as per the Annex II.
This certificate is issued to the manufacturers of the medical devices that comply with the conformity assessment specified in chapter II of Annex IX of MDR. It is applicable for all classes of medical devices that require notified body intervention for their CE Marking process. This certificate includes clear product identification (name, model, type of device or devices), intended purpose, risk classification, and Basic UDI- DI. The CE certificates issued are valid for a maximum of 5 years and will be renewed by annual surveillance audit.
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For the medical devices incorporating the medicinal substance as per the directive 2001/83/EC, before issuing the above-said certificate, what is the Notified Body required to do?
1. The notified body seeks a scientific opinion which has been consulted on the quality and safety of the substance including the benefit or risk of the incorporation of the medicinal substance into the device considering the intended purpose of the device .
2. The medicinal products authority consulted shall provide its opinion considering into account the manufacturing process and the data relating to the usefulness of incorporation of the substance into the device to notified body within 120 days.
3. In the documentation of the notified body concerning the device the scientific opinion of the medicinal products authority should be included with due consideration to the views expressed when making its decision. If the scientific opinion is unfavorable the notified body shall not deliver the certificate and shall convey the medicinal products authority consulted is final decision.
4. Any change made with respect to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the manufacturer shall inform the notified body of the changes then notified body shall seek the opinion of the medicinal products authority consulted, in order to confirm that the quality and safety of the ancillary substance remain unchanged. The medicinal products authority consulted shall consider into account the data relating to the usefulness of incorporation of the substance into the device, in order to ensure that changes made have no negative impact on the risk or benefit previously established concerning the incorporation of the substance into the device. The medicinal products authority consulted should provide its opinion within 60 days after receipt of all the necessary documentation regarding the changes. The notified body shall not deliver the supplement to the EU technical documentation assessment certificate if the scientific opinion provided by the medicinal products authority consulted is unfavorable. The notified body should convey its decision to the medicinal products authority consulted.
5. Where the medicinal products could have an impact on the risk or benefit previously established concerning the incorporation of the substance into the device, it shall advise the notified body as to whether this information has an impact on the risk or benefit previously established concerning the incorporation of the substance into the device. The notified body shall consider that advice into account during its assessment of the conformity assessment procedure.
As per section 5.2, Chapter I, Annex IX of EU MDR,
Before issuing an EU technical documentation assessment certificate, the notified body should,
seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA, on the quality and safety of the medicinal substance, including the benefit or risk of the incorporation of the substance into the device.
Where the device incorporates a human blood or plasma derivative or a substance that, if used separately, may be considered to be a medicinal product falling exclusively within the scope of the Annex to Regulation (EC) No 726/2004, the notified body shall seek the opinion of the EMA.
The competent authority or EMA should provide its opinion to the notified body within 210 days of receipt of all the necessary documentation.
If the scientific opinion is unfavourable, the notified body should not deliver the certificate, and should convey its final decision to the competent authority or EMA.
Post certification, if there is any change in manufacturing process planned by the manufacturer, with respect to the ancillary substance incorporated in the device, then before that change, the manufacturer should inform the concerned notified body about the changes. That notified body should seek opinion from competent authority or EMA again, in order to confirm that the quality and safety of the ancillary substance remain unchanged.
In this case, the competent authority or EMA should provide its opinion to the notified body within 60 days of receipt of all the necessary documentation.
If the scientific opinion is unfavourable, the notified body should not deliver the supplement to the EU technical documentation assessment certificate, and should convey its final decision to the competent authority or EMA.