2017/745_AnnexI  _ II_III_ IV_ V_ VI_ VII_ VIII_IX_X_XI_XII_XIII_XIV_XV_XVI_XVII

Article 90
Analysis of vigilance data


The Commission shall, in collaboration with the Member States, put in place systems and processes to actively monitor the data available in the electronic system referred to in Article 92, in order to identify trends, patterns or signals in the data that may reveal new risks or safety concerns.

Where a previously unknown risk is identified or the frequency of an anticipated risk significantly and adversely changes the benefit-risk determination, the competent authority or, where appropriate, the coordinating competent authority shall inform the manufacturer, or where applicable the authorised representative, which shall then take the necessary corrective actions.

Article 91
Implementing acts


The Commission may, by means of implementing acts, and after consultation of the MDCG, adopt the detailed arrangements and procedural aspects necessary for the implementation of Articles 85 to 90 and 92 as regards the following:

(a)

the typology of serious incidents and field safety corrective actions in relation to specific devices, or categories or groups of devices;

(b)

the reporting of serious incidents and field safety corrective actions and field safety notices, and the provision of periodic summary reports, post-market surveillance reports, PSURs and trend reports by manufacturers as referred to in Articles 85, 86, 87, 88 and 89 respectively;

(c)

standard structured forms for electronic and non-electronic reporting, including a minimum data set for reporting of suspected serious incidents by healthcare professionals, users and patients;

(d)

timelines for the reporting of field safety corrective actions, and for the provision by manufacturers of periodic summary reports and trend reports, taking into account the severity of the incident to be reported as referred to in Article 87;

(e)

harmonised forms for the exchange of information between competent authorities as referred to in Article 89;

(f)

procedures for the designation of a coordinating competent authority; the coordinated evaluation process, including tasks and responsibilities of the coordinating competent authority and involvement of other competent authorities in this process.

The implementing acts referred to in the first paragraph  shall be adopted in accordance with the examination procedure referred to in Article 114(3).