1. Legal Requirements

According to Article 74(1) MDR, a Post-Market Clinical Follow-up investigation (PMCF investigation) is a clinical investigation conducted after the medical device has been placed on the market for the purpose of further assessment of that device.

Furthermore, this clinical investigation is carried out with the medical device within the scope of its intended purpose, which is covered by the CE conformity marking in accordance with Article 20(1) MDR.

In addition, this clinical investigation would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome (Article 74(1) MDR).

If a post-marketing clinical investigation fulfils the conditions set out in Article 74(1) of Regulation (EU) 2017/745, the sponsor shall notify the federal higher authority (and the Member States concerned) at least 30 days before the start of the investigation. The notification shall be made via the electronic system referred to in Article 73 MDR. 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 (DMIDS).

In accordance with Article 74(2) MDR, the procedure under Article 74(1) MDR does not apply to clinical investigations for the assessment of a medical device that already bears the CE marking but is used outside the scope of its intended purpose. In this case, Articles 62 to 81 MDR shall apply and an application for authorisation shall be submitted accordingly.

2. Application Documents

The sponsor shall submit the documentation referred to in Annex XV Chapter II MDR as part of the notification.

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

3. Notification and Beginning of Clinical Investigations in Accordance with Article 74(1) MDR

The procedure according to Article 74(1) MDR is a notification procedure to the federal higher authority according to § 85(2) No. 6 MPDG, which is notified by the sponsor via the electronic system referred to in Article 73 MDR. 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 (DMIDS). The federal higher authority receives the notification of the clinical investigation. The sponsor must submit the notification at least 30 days before the start of the clinical investigation.

4. Additional Applicable Legal Provisions for Clinical Investigations According to Article 74(1) MDR

• Article 62(4) point b to k and m of Regulation (EU) 2017/745 (MDR)
• Articles 75 to 77 of Regulation (EU) 2017/745 (MDR)
• Article 80(5) and (6) of Regulation (EU) 2017/745 (MDR)
• the relevant provisions of Annex XV of Regulation (EU) 2017/745 (MDR)
• the relevant paragraphs of the Medical Devices Law Implementation Act (MPDG)

5. Reporting Obligations in Post-Market Clinical Follow-up Investigations in Accordance with Article 74(1) MDR

As specified in Article 80(5) of Regulation (EU) 2017/745 (MDR), the provisions on vigilance (incident reporting requirements) laid down in Articles 87 to 90 and in the acts adopted pursuant to Article 91 shall apply.

In addition, serious adverse events must be reported by the sponsor to the competent authority where a causal relationship between the serious adverse event and the preceding investigational procedure has been established (Article 80(6) MDR).

6. Special Notes

• For clinical investigations with medical devices that do not involve invasive and burdensome procedures, which already bear a CE mark and whose use within the clinical investigation is within the scope of its intended purpose, no approval assessment by the ethics committee and no notification to the federal higher authority is required.
• However, the obligation of ethical counselling for investigators who are involved in research projects, which arises from the medical professional law, must be taken into account.
• For a clinical investigation intended to assess a medical device already bearing the CE marking but outside its intended purpose, Articles 62 to 81 MDR apply.

6. Legal Bases

• Regulation (EU) 2017/745 (MDR)
• Medical Device Law Implementation Act („Medizinprodukterecht-Durchführungsgesetz“, MPDG) - current version