In accordance with the Regulation of the Minister of Health of December 12, 2022 on the model form for reporting a serious incident issued pursuant to Article 48 (13) of the Law of April 7, 2022 on Medical Devices (Journal of Laws, item 974),
1. Serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:
1) the death of a patient, user or other person;
2) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health;
3) a serious public health threat.
Incident means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.
2. A serious incident that happened on the territory of the Republic of Poland may be notify by any person.
3. Notification of serious incident is obligatory for the entities or persons indicated in Art. 48 (2) of the Act of April 7, 2022 on medical devices.
4. Notification of a serious incident may be sent by mail or by email.
5. Notification of a serious incident shall be sent to the manufacturer or his authorized representative, and a copy of the notification shall be sent to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (President of the Office). The copy of the notification may be sent by email on address incydenty@urpl.gov.pl .
6. If the manufacturer or his authorized representative does not have a seat or place of residence on the territory of the Republic of Poland, the notification may be sent to the supplier of the product, and a copy of the notification may be sent to the President of the Office.
7. If the address of the manufacturer or the authorized representative cannot be determined, the notification of a serious incident shall be sent to the supplier of the product having its place of residence or seat on the territory of the Republic of Poland, and a copy of the notification shall be sent to the President of the Office.
8. An entity/person notifying about serious incident is obliged to provide the manufacturer, an authorized representative and entities authorized by them, as well as the President of the Office with the necessary assistance in the investigation in order to establish a causal link between the device and the notified serious incident, in particular, it is obliged to provide the necessary information and make the device available for research and assessment and also devices and products used with the device when the serious incident occurred. The obligation of making the product available does not apply to lay person.
9. Information on the processing of personal data:
Processing of personal data by the recipient of this notification must be conducted in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1–88 with amend.).
Notifier of serious incident is obliged of pseudonymization of patient or patients personal data in this form. In case when notifier is a physical person being subject of serious incident (patient) providing of this notification means permission for processing of provided personal data of the notifier by the recipient of the notification indicated in the part 2, which is controller of these personal data. If notifying physical person, being victim of serious incident does not allow processing of its personal data by the entity being informed about serious incident, then sends this notification to the President of the Office only with request of pseudonimization of its personal data by President of the Office before forwarding of this notification to the recipient described in part 2.
Physical persons whose personal data are provided in the notification keep the right of access to data relating to them, and the right to have inaccurate or incomplete data corrected and erased. Corrections and deletions shall be carried out as soon as possible, but no later than 60 days after a request is made by a data subject. Personal data shall be kept in a form which permits identification of data subjects for periods no longer than those referred to in Article 10(8) of Regulation Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1–175 with amend.). Information (in Polish only) on the processing of personal data by the President of the Office is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (http://urpl.gov.pl/pl/daneosobowe).
Providing of the telephone number and e-mail address as well as the name and surname of the contact person is optional, however providing these data will help the manufacturer or the authorized representative to contact the notifier and will allow faster investigation of the cause of the serious incident.
The completed form should be sent to the Diagnosis e-mail address (address: diagnosis@diagnosis.pl) or by post to the following address: Diagnosis S.A., ul. Gen. W. Andersa 38A, 15-113 Bialystok, Poland
