Medical Device Q&A MDCG 2021-6 / Regulation (EU) 2017/745 (Part 3)
- What is considered burdensome or invasive?
- Where the 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, the Sponsor shall notify the Member States concerned at least 30 days prior to its commencement, in accordance with Article 74(1) of the MDR.
- Additional procedures which are burdensome can include a wide variety of different interventions, this may include procedures which may cause pain, discomfort, fear, potential risks or complications/side-effects, disturbances of lives and personal activities, or otherwise unpleasant experiences. It is mostly determined from the perspective of the person bearing the burden.
- Additional procedures which are invasive include (but are not limited to) penetration inside the body through the surface of the body, including through mucous membranes of body orifices, or penetration of a body cavity via a body orifice.
- The understanding of what is considered to be invasive or burdensome is expected to develop over time.
- Sponsors are encouraged to document their assessment whether the additional procedures imposed by the clinical investigation plan are considered as burdensome and/or invasive, and where appropriate, contact the relevant authority in the Member State(s) to discuss cases where the sponsor is uncertain.
- Who is responsible for determining the correct regulatory pathway for a clinical investigation?
- It is the sponsor’s responsibility to determine the correct regulatory pathway for their clinical investigation. Guidance is provided in this document, but the MDR and national legislation contain the legally binding requirements.
- Note that the MDR introduces a requirement for manufacturers to have access to a Person Responsible for Regulatory Compliance (Article 15 of the MDR).
- Sponsors are encouraged to document their assessments and choices of regulatory pathways.
- If the sponsor is uncertain about which route to apply for a particular clinical investigation, the National Competent Authority may be consulted.
- What are the safety reporting requirements for clinical investigations?
- The requirements for safety reporting will depend on whether you are using the investigated medical device within its intended purpose:
- If the investigated medical device is CE marked and will be used within its intended purpose, the provisions on vigilance laid down in Article 80(6) and Articles 87 to 90 of the MDR and the acts adopted pursuant to Article 91 of the MDR shall apply for PMCF clinical investigations.
- If the investigated medical device is not CE marked, or is CE marked but will be used outside its intended purpose, the provisions on safety reporting laid down in Article 80 of the MDR shall apply.
- Please refer to MDCG 2020-10/1 ‘Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745’ for further guidance.
- Does a manufacturer of devices without a medical purpose included in Annex XVI of Regulation (EU) 2017/745 (MDR) have to conduct clinical investigations?
- To ensure the same level of protection of consumers for some products which could be similar to medical devices but without a medical purpose, devices described in Annex XVI to the MDR have to comply with the applicable general safety and performance requirements.
- Clinical evaluations of those products shall be based on relevant data concerning safety, including data from post-market surveillance, PMCF, and, where applicable, specific clinical investigations. Clinical investigations shall be performed for those products unless reliance on existing clinical data from an analogous medical device is duly justified
- Please refer to MDCG 2020-5 Clinical Evaluation – Equivalence, section 4 (f) for further guidance.
- Are coordinated assessment procedures in accordance with Article 78 of Regulation (EU) 2017/745 (MDR) available?
- For the time being, no coordinated procedure is available.
- What procedure applies for clinical investigations of custom-made devices or in-house manufactured devices?
- Custom-made devices are defined in Article 2(3) of the MDR.
- In-house manufacturing, modifying and use of devices within health institutions is provided for in Article 5(5) of the MDR.
- The relevant general safety and performance requirements set out in Annex I of the MDR apply to both of these device types. As such, clinical investigations may be undertaken with respect to these device types, and they may fall under Article 62 or 82.
