MDR requirements for PMCF investigations

Manufacturers should be careful to distinguish a PMCF investigation from other types of PMCF

MDR Article 74, Clinical investigations regarding devices bearing the CE marking, refers to a post-market clinical follow-up (PMCF) investigation as a clinical investigation conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking.

Manufacturers should be careful to distinguish a PMCF investigation from other types of PMCF, some of which are referred to in MDR Annex XIV, Part B, Section 6.2, such as: gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data, or evaluation of suitable registers. These types of PMCF are different from a PMCF investigation, which is subject to a series of requirements, specified in MDR Article 74, some of which are the same as those applicable to pre-market clinical investigations.

In seeking to comply with MDR Article 74, it is very important to determine whether the PMCF investigation is planned to be conducted exactly in accordance with standard practice and the device’s instructions for use (IFU) or whether any additional procedures (e.g. additional blood analyses, diagnostic X-rays or scans, or other procedures) are planned and, if additional procedures are planned, whether they are invasive or could be considered burdensome. This is because MDR Article 74 specifies that where a PMCF investigation involves submitting subjects to procedures additional to those performed under normal conditions of use, and those additional procedures are invasive or burdensome, the sponsor must notify the Member States concerned at least 30 days before the study commences, by means of the electronic system referred to in MDR Article 73.

The sponsor of a PMCF investigation that involves additional procedures that are invasive or could be considered burdensome is also required to include documentation referred to in MDR Annex XV, Clinical Investigation, Chapter II, Documentation Regarding the Application for Clinical Investigation, as part of the notification. This documentation is the same type of documentation required for pre market clinical investigations.

Revised ISO 14155 includes Annex I (informative), Clinical development stages, which is a new annex, that includes Section I.6, Burden to subjects. This section should be useful in considering factors that are important for complying with MDR Article 74. This is because this section provides information on the categorization of clinical investigations based on interference with normal clinical practice.

Regarding compliance with adverse event reporting, MDR Article 80(5) requires that in the case of PMCF investigations, the provisions on vigilance laid down in MDR Articles 87 to 90 and in the acts adopted pursuant to MDR Article 91 apply.

MDR Article 80(6), however, states the following:

‘Notwithstanding paragraph 5, this Article shall apply where a causal relationship between the serious adverse event and the preceding investigational procedure has been established.’

By ‘this Article shall apply’, Article 80(6) is referring to MDR Article 80(1) through (4).

That is, manufacturers will need to determine whether a serious incident has occurred, which needs to be reported under MDR vigilance requirements as specified in MDR Articles 87 to 90 or whether a serious adverse event has occurred, which meets the requirements of Article 80(6) and needs to be recorded and reported as specified in Article 80(1) to (4).

This is an excerpt from the BSI medical devices white paper: Medical device clinical investigations – What’s new under the MDR? To browse our collection of medical device white papers, please visit the Insight page on the Compliance Navigator website.