Procedure for clinical investigations of medical devices that already bear the CE marking

The MDR establishes specific regulations for clinical investigations involving CE-marked medical devices, particularly when invasive or burdensome procedures are planned for study participants. It defines clear responsibilities for sponsors and authorities.

If a is conducted on a medical device

-       that already bears the CE mark,

-       and if this clinical investigation is carried out within the device's intended purpose

-       while involving invasive or burdensome procedures for study participants,

special regulations apply. These are outlined in Article 74 of EU Regulation 2017/745 (Medical Device Regulation, MDR).

In the context of, invasive and burdensome procedures refer to additional medical interventions or examinations that exceed the normal use of the medical device and pose extra burdens or risks to study participants.

Examples of invasive procedures are:

• Blood draws beyond the usual amount
• Tissue sampling
• Endoscopies (e.g., examinations of the stomach and intestines)
• Catheter examinations
• Spinal fluid extraction
• Implantation of sensors or devices

Examples of burdensome procedures are:

• Additional X-rays or CT scans
• Significantly longer or more frequent examination appointments
• Restrictions in daily activities (e.g., specific diets or movement limitations)
• Psychological tests or surveys on sensitive topics
• Provocation tests (e.g., allergy tests)
• Prolonged hospital stays

Important to know: for CE-marked medical devices where a different (new) intended purpose is to be examined, Articles 62 to 81 of the MDR apply.

‍Sponsor responsibilities in clinical investigations of CE-marked medical devices with planned additional invasive or burdensome procedures:

-      Authorities of the relevant member states where the clinical investigation is conducted must be informed in a timely manner.

-      All documents as per Annex XV Chapter II must be submitted. This includes:

• The application form with specific information,
• Investigator details,
• The complete clinical investigation plan in accordance with ISO 14155,
• Additional documents such as ethical considerations, CVs of investigators, proof of insurance, informed consent forms, and declarations of compliance with good clinical practice principles.

-     Approval from an ethics committee is required to protect vulnerable populations, assess risk-benefit ratios, ensure informed consent after adequate explanation, protect personal data, verify the qualifications of medical personnel, and prohibit undue influence on participants (Article 62(4)(b-k and m)).

-      Adherence to responsibilities as sponsors and investigators during the conduct of the clinical investigation (Article 75).

-      Submission of documentation via an electronic system (Articles 76 and 77; note: this is not expected to be available in 2024).

-      Vigilance requirements: reporting obligations for incidents and serious adverse events to the competent authority when a causal link between the event and the investigation procedure is established (according to Articles 80(5) and (6) and Articles 87 to 91).

Important to note: Clinical investigations for CE-marked medical devices conducted within their intended purpose and without invasive or burdensome procedures are not regulated by the MDR. These special types of clinical investigations are governed by national laws in Europe. In Germany, this includes the Medical Devices Law Implementation Act and possibly the Professional Code for Physicians (BOÄ).

Benefit from our extensive experience in the design and conduct of clinical investigations, and contact contact us for an initial consultation.

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