1. Legal Requirements

According to Regulation (EU) 2017/746 (IVDR) Article 70(1), performance studies that are conducted to further assess a device that already bears the CE marking in accordance with Article 18(1) of the IVDR and where the use is within the scope of its intended purpose are referred to as a "post-market performance follow-up study" ("PMPF study").

Furthermore, if subjects are submitted to additional procedures to those carried out under normal conditions of use of the device as part of this post-market performance study (PMPF), and if these additional procedures are invasive or burdensome, the sponsor shall notify the Member States concerned at least 30 days before the commencement of the performance study (Article 70(1) IVDR). The notification shall be made via the electronic system referred to in Article 69. As long as the European database EUDAMED is not available for this purpose, the notification shall be made via the German Medical Devices Information and Database System (“Deutsches Medizinprodukte-Informations- und Datenbanksystem”, DMIDS).

In accordance with Article 70 (2) of the IVDR, the procedure laid down in Article 70 (1) of the IVDR does not apply to performance studies for the assessment of a device which already bears the CE marking but which is used outside the scope of its intended purpose. In this case, Articles 58 to 77 of the IVDR shall apply and an application for authorisation shall be made accordingly.

2. Application Documents

The documents according to Annex XIII Part A Section 2 and Annex XIV of the IVDR are submitted by the sponsor as part of the notification (Article 70(1) IVDR).

Here, according to Annex XIV Chapter I, Number 4.2 in conjunction with the German Medical Devices Law Implementation Act (“Medizinprodukterecht-Durchführungsgesetz”, MPDG) § 31a Paragraph 2, it must be noted in particular that the procedure in Germany is sequential. First, the application must be submitted to the competent ethics committee. Only then can the application be submitted to the higher federal authority. The application or the notification to the higher federal competent authority must be accompanied by the favourable opinion of the ethics committee.

3. Notification and Commencement of Performance Studies according to Article 70(1) IVDR

The procedure according to Article 70(1) of Regulation (EU) 2017/746 (IVDR) is, pursuant to the German Medical Devices Law Implementation Act (MPDG) § 85(2) No. 6, a notification procedure to the higher federal authority, which is communicated by the sponsor via the electronic system referred to in Article 69 IVDR. As long as the European database EUDAMED is not available for this purpose, the notification must be made via the German Medical Devices Information and Database System (“Deutsches Medizinprodukte-Informations- und Datenbanksystem”, DMIDS). The higher federal competent authority receives the notification of the performance study. The sponsor must submit the notification at least 30 days before the start of the performance study.

4. Additional Applicable Regulatory Requirements for Performance Studies under Article 70(1) of the IVDR

• Article 58(5) (b) to (l) and (p) of Regulation (EU) 2017/746 (IVDR)
• Articles 71 to 73 of Regulation (EU) 2017/746 (IVDR)
• Article 76 (5) and (6) of Regulation (EU) 2017/746 (IVDR)
• the relevant provisions of Annex XIII and XIV to Regulation (EU) 2017/746 (IVDR)
• the relevant paragraphs of the Medical Devices Law Implementation Act
  (“Medizinprodukterecht-Durchführungsgesetz”, MPDG)

5. Reporting Obligations in Post-Marketing Performance Follow-up Studies pursuant to Article 70(1) of the IVDR

As required by Article 76 (5) of Regulation (EU) 2017/746 (IVDR), the provisions on vigilance laid down in Articles 82 to 85 and in the implementing acts adopted pursuant to Article 86 shall apply.

In addition, serious adverse events (SAEs) are to be reported by the sponsor to the competent authority where a causal relationship between the serious adverse event and the preceding performance study has been established (Article 76(6) IVDR).

6. Special Notes

For performance studies in which the subjects are not submitted to invasive and burdensome procedures compared to the regular use of the product, which already bear a CE mark and whose use within the performance study takes place within the scope of the certified intended purpose, no favourable opinion by the ethics committee and no notification to the higher federal authority is required.

However, the obligation of ethical counselling for investigators involved in research projects, which arises from the medical professional law (“Berufsordnung für Ärzte”), must be observed.

Articles 58 to 77 IVDR apply to a performance studies that is conducted to assess, outside its intended purpose, a device, which already bears the CE marking.

7. Legal Bases

• Regulation (EU) 2017/746 (IVDR) - latest version.
• Medical Devices Implementation Act (“Medizinprodukterecht-Durchführungsgesetz”, MPDG) - latest version