In Germany, the legislation provides for a cut-off date for the transition to the new legislation for clinical investigations of medical devices. This means that all applications must be submitted and processed according to the legislation valid until then (MPG and associated laws) until Regulation (EU) 2017/745 (MDR) and the Medizinprodukterecht-Durchführungsgesetz (MPDG) come into effect on 26 May 2021. From that date onwards, the MDR with the supplementary national legislation (MPDG) will immediately and exclusively be the basis for submissions and assessments. Until the start of the application of the MDR, the documents submitted in the context of an application for authorisation of a clinical investigation must therefore comply with the requirements of the applicable legislation (MDD 93/42 / EEC, MPG); from then on, they must comply with the legislation applicable with the start of the validity of the MDR.

All clinical investigations that are not considered initiated in the sense of the law (§ 99 MPDG) on the cut-off date must be reapplied for and reassessed according to the new legislation; a continuation or even a completion of the assessment on the basis of the previously submitted application documents is not possible for legal reasons.

In Germany, a clinical investigation of a medical device is considered to have been initiated if it has already been approved by the competent authority on the cut-off date (currently 26.05.2021) and the favourable opinion of the ethics committee(s) has also been obtained (Section 99 (3) MPDG). If one of the two conditions is not met, a new application is required in accordance with the MDR requirements.

Clinical investigations which, according to current legislation, do not require approval by the competent authority before 26.05.2021 are deemed to have been initiated within the meaning of the law if the first subject has declared his or her consent to participate before the cut-off date (Section 99 (4) MPDG).

Clinical investigations that are considered already initiated on the cut-off date may be continued on the basis of the legislation in force before the cut-off date.

The cut-off date regulation is laid down in § 99 Para. 3 ff. of the MPDG.

It should also be noted that the application procedure is sequential from the date of application of the MDR in Germany: First, the application must be submitted to the ethics committee, and only then can the application for the clinical investigation be submitted to the federal higher authorities. From the beginning of the MDR / MPDG, the application documents must be accompanied by the favourable opinion of the ethics committee.

A preliminary remark:

In order to avoid misunderstandings, it should be noted that the term "other clinical investigation", which has been used in practice up to now, is not legally defined. As a rule, this refers to clinical investigations of medical devices that require the consultation of an ethics committee in accordance with the medical professional code of conduct (“ärztliche Berufsordnung”), but are not subject to an approval procedure under medical device law. In addition to clinical investigations which fulfil the criteria according to § 23b MPG, this also includes clinical investigations which are carried out, for example, for fundamental research questions for purely scientific reasons.

A distinction must be made between these and the term "other clinical investigation" introduced by Article 82 MDR, which is defined by Section 3 No. 4 of the MPDG in Germany. It includes clinical investigations that are conducted to answer purely scientific questions and that are not conducted as part of a conformity assessment procedure, a planned product development or a development plan (according to Annex XIV Part A No. 1 letter a of the MDR) for a medical device.

What is a PMCF investigation?

A PMCF (Post Market Clinical Follow-up) investigation in the sense of the MDR is understood to be a clinical study with a medical device after it has been placed on the market. The investigational device is used in accordance with its intended purpose as defined for the CE mark. The purpose of the investigation is to systematically collect clinical data for the purpose of evaluating the safety and/or performance of a device (see Article 2 No. 45 of the MDR).

PMCF investigation without additional invasive or burdensome procedures in the context of the MDR and the MPDG:

For these clinical investigations, there is neither an obligation to notify nor an obligation to obtain approval from the ethics committee or the federal higher authorities. However, the obligation of consultation according to professional law for physicians (see § 15 of the respective professional regulations (“ärztliche Berufsordnung”)) by the ethics committees remains unchanged.

Serious adverse events (SAEs) do not have to be reported to the federal higher authorities; the vigilance provisions remain valid without restriction.

The handling in Germany thus corresponds to the former regulation in the MPG for clinical investigations which fulfil the criteria according to § 23b MPG.

Other clinical investigation according to Article 82 MDR with a device after it has been placed on the market, which is used in the context of its intended purpose and in which the subjects are not exposed to any additional invasive or burdensome procedures:

Section 47, paragraph 3 of the MPDG suspends the requirements of paragraphs 1 and 2 of the same section. This includes the necessity of a favourable opinion by the ethics committee and the obligation to notify the federal higher authorities.

The incident reporting obligations are to be observed. The obligation to report serious adverse events (SAEs) is abolished by Section 64, paragraph 4 of the MPDG for these clinical investigations. However, obligations arising from the professional code of conduct for physicians (“ärztliche Berufsordnung”), e. g. consultation according to professional law when participating in research projects, remain unaffected.

If applicable, further provisions resulting from other legal requirements must be taken into account when conducting the clinical investigation.

Information on SAE and DD reporting requirements can be found in the Applications and Reports section.