Since the MDR comes applicable on 26.05.2021, the reporting of serious adverse events (SAEs) and device deficiencies (DDs) must be carried out in accordance with the European Regulation 2017/745 (MDR) in conjunction with the Medical Devices Law Implementation Act (“Medizinprodukterecht-Durchführungsgesetz”, MPDG) for all clinical investigations that must be applied for or notified to the federal higher authority.

This also applies to clinical investigations that were commenced under the legal framework of the MPG (MDD) and are considered to have been initiated within the meaning of Section 99 (3) - (5) MPDG when the MDR came applicable on 26.05.2021 and for which SAEs were previously to be reported to the federal higher authority in accordance with the MPSV.

Since the IVDR came applicable on 26.05.2022, the reporting of serious adverse events (SAEs) and device deficiencies (DDs) must be carried out in accordance with the European Regulation 2017/746 (IVDR) in conjunction with the Medical Devices Law Implementation Act (“Medizinprodukterecht-Durchführungsgesetz”, MPDG) for all clinical investigations that must be applied for or notified to the federal higher authority.

Note: This does not apply to performance evaluation studies that were initiated under the legal framework of the MPG and are considered to have been begun at the date of application of the IVDR on 26.05.2022 within the meaning of Section 100 (3) MPDG. For these performance evaluation studies, the legal framework of the MPG and its associated ordinances, including the Medical Devices Safety Plan Ordinance (“Medizinprodukte-Sicherheitsplanverordnung”, MPSV), continues to apply.