EUDAMED Datenbank Update App-Version 2.7.0

Update the Enumeration for the  Nomenclature Code field (FLD-UDID-149)- to EMDN Nomenclature

Update FLD-UDID-39 (DD Legacy Devices). Update Occurrence and description

FLD-CRF-240 Scientific opinion

FLD-CRF-239 Justification (for not following the scientific opinion)

Update of Enumeration for Special Device types (split by Applicable Legislation) – BR-UDID-818 : Special Device Type – ENUM_UDID_SpecialDevice

BR-CRF-220 – Only active (not yet expired) certificates not in status WITHDRAWN can be requested for suspension/withdrawal by a Designating Authority;

BR-CRF-229 – Expert panel rapporteurs are no allowed to request for change their profile;

BR-CRF-233 – Mandatory to provide the validity period of the nominated expert panel list document;

BR-CRF-234 – Constraints when registering a new SS(C)P version;

BR-CRF-240 – Mandatory provision of comments in all certificate languages

BR-CRF-241 – Mandatory to reference a Manufacturer and/or SPP Producer when registering a request for suspension/withdrawal

of certificates not yet registered in EUDAMED by a Designating Authority;

BR-CRF-243 – Provision of decision document when registering an application;

BR-CRF-245 – Specific criteria when searching for certificates to be merged;

BR-CRF-251 – Possibility to change a quality certificate scope when restricting or reissuing a quality certificate type containing devices and systems and/or procedure packs sterilisation;

BR-CRF-261 – Viewing discarded requests for suspension/withdrawal of certificates;

BR-CRF-262 – A DA can register requests for suspension/withdrawal of certificates only for certificates issued by Notified Bodies that are under responsibility of that DA.

Changed

BR-CRF-163 – Scientific opinion document will be mandatory to provide if applicable.

Depending on the outcome from the screening panel if the opinion will be provided or not. When opinion will be provided, Notified Bodies must provide the scientific opinion document within the mechanism for scrutiny step of certificate registration; BR-CRF-249 – Possibility to add/remove languages when amending or reissuing a certificate.

• Possibility to set/update the first country where the device has been put on the EU market via Update of UDI- DI service;
• Registering a Market Information entity via the „Update of market Information“ service.

5.1.2 XSD element changes

• CorrelationID and ConversationID now behave consistently as described;
• Field name update: previousIdentifiers to precedingCertificates;
• The payload of a certificate now contains link(s) to the preceding certificate(s) (Note: There can be multiple
  preceding certificates in case when merging two or more certificates during the reissue operation);
• The payload of a certificate that had a decision or update now contains information about the
  statusChangeReason, decision document and comments where applicable;
• Device upload: „links:certificateType is not valid“ error corrected;

• Unexpected error „sutures from the submitted version of Basic UDI-DI/EUDAMED DI have different values
  than the ones existing in EUDAMED“ fixed;

• Possibility to set/update the first country where the device has been put on the EU market via Update of UDI- DI service;
• Registering a Market Information entity via the „Update of market Information“ service.

5.1.2 XSD element changes

• CorrelationID and ConversationID now behave consistently as described;
• Field name update: previousIdentifiers to precedingCertificates;
• The payload of a certificate now contains link(s) to the preceding certificate(s) (Note: There can be multiple
  preceding certificates in case when merging two or more certificates during the reissue operation);
• The payload of a certificate that had a decision or update now contains information about the
  statusChangeReason, decision document and comments where applicable;
• Device upload: „links:certificateType is not valid“ error corrected;

• Unexpected error „sutures from the submitted version of Basic UDI-DI/EUDAMED DI have different values
  than the ones existing in EUDAMED“ fixed;

• Possibility to set/update the first country where the device has been put on the EU market via Update of UDI- DI service;
• Registering a Market Information entity via the „Update of market Information“ service.

5.1.2 XSD element changes

• CorrelationID and ConversationID now behave consistently as described;
• Field name update: previousIdentifiers to precedingCertificates;
• The payload of a certificate now contains link(s) to the preceding certificate(s) (Note: There can be multiple
  preceding certificates in case when merging two or more certificates during the reissue operation);
• The payload of a certificate that had a decision or update now contains information about the
  statusChangeReason, decision document and comments where applicable;
• Device upload: „links:certificateType is not valid“ error corrected;

• Unexpected error „sutures from the submitted version of Basic UDI-DI/EUDAMED DI have different values
  than the ones existing in EUDAMED“ fixed;