Clinical data for medical devices

Clinical data is the evidence to demonstrate and continuously support clinical benefit, safety, and performance that is generated from the use of a device(s) and is sourced from the following:

• Clinical investigation(s) of the device under evaluation,
• Clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device under evaluation can be demonstrated,
• Scientific articles and reports published in peer reviewed scientific literature related to either the device under evaluation, or a device for which equivalence to the device under evaluation can be demonstrated,
• Clinically relevant information coming from post-market surveillance.

CLINICAL DATA SOURCED FROM CLINICAL INVESTIGATION OF THE DEVICE UNDER EVALUATION

Clinical investigation of medical device(s) is any systematic investigation, undertaken to assess the safety, performance, and clinical benefit. Clinical investigations shall be based on a plan that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of the clinical investigation.

The MDR sets the legal framework in Annex XV on clinical investigations including the involvement of the competent authorities and the ethical committees.

For further guidance see ISO 14155, MDCG 2021-6 and MDCG 2024-3.

CLINICAL DATA SOURCED FROM SCIENTIFIC LITERATURE

A clinical evaluation may be based on clinical data published in scientific literature relating to the device under evaluation or to a device for which equivalence to the device under evaluation was demonstrated.

For the appropriate literature search, a search protocol is necessary. Here the manufacturer should clearly identify the adequacy of search terms: for example, it should be sufficiently broad to establish benchmarks, determine the general state of the art, determine potential risk, adverse events, and undesirable side-effects, as written in MDCG 2020-13.

Following this guidance, more aspects of an appropriate and transparent literature search and literature appraisal shall be considered, such as multiple databases should be used, both favorable and unfavorable data must be included.

For further guidance see MDCG 2020-13.

EQUIVALENCE UNDER MDR

The following technical, biological and clinical characteristics MUST be considered for the demonstration of equivalence (MDR Annex XIV part A 3):

Technical: the device is of SIMILAR design, conditions of use, specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses SIMILAR deployment methods, where relevant and has SIMILAR principles of operation and critical performance requirements. 

Biological: the device uses the SAME materials or substances in contact with the SAME human tissues or body fluids for a SIMILAR kind and duration of contact and SIMILAR release characteristics of substances, including degradation products and leachable.

Clinical: the device is used for the SAME clinical condition or purpose, including SIMILAR severity and stage of disease, at the SAME site in the body, in a SIMILAR population (age, anatomy and physiology) has the SAME kind of user and SIMILAR relevant critical performance.

For further guidance see MDCG 2020-5.

Clinical data sourced from post market surveillance

The Post Market Surveillance Plan shall be drawn up by the manufacturer in accordance with Articles 83 to 86. It shall be presented in a clear, organized, readily searchable and unambiguous manner and shall include in particular the elements described in Annex III of the MDR.

POST MARKET CLINICAL FOLLOW-UP (PMCF)

PMCF is an integral part of Post Market surveillance and is based on a PMCF plan that shall include at least the requirements laid out in MDR Annex XIV part B, 6.2 concerning the general and specific methods of PMCF.

• General Methods and procedures should be understood as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data,
• Specific Methods and procedures should be understood as clinical data emerging from PMCF studies or suitable registry data.

For further guidance see MDCG 2020-7 and MDCG 2020-8.

PERIODIC SAFETY UPDATE REPORT (PSUR)

Manufacturers of class IIa, class IIb and class III devices shall prepare a PSUR (MDR Art. 86). The PSUR shall include the conclusion of the benefit-risk determination, the main findings of the PMCF including the volume of sales and other characteristics of the population using the device.

The PSUR shall, except in the case of custom-made devices, be part of the technical documentation.

The PSUR for Class IIb and Class III devices should be updated annually or sooner if critical clinical data that could impact the benefit-risk assessment has been gathered.

For further guidance see MDCG 2022-21.

SUMMARY OF SAFETY AND CLINICAL PERFORMANCE (SSCP)

The Summary of Safety and Clinical Performance (SSCP) is a critical component of the EU Medical Devices Regulation (EU MDR), specifically for Class III and implantable medical devices (MDR art. 32). It serves as a comprehensive document that provides healthcare professionals and the public with updated clinical data about safety and clinical performance for the device under evaluation. The SSCP includes details such as device description, intended purpose, associated quantified risks, warnings, post market information, and an objective summary of clinical data including the benefit. Manufacturers are responsible for updating the SSCP to align with the most current clinical evaluation report. This transparency is crucial for maintaining trust in the medical devices available on the EU market.

It must be written in a way that it is clear to the intended user and, if relevant, to the patient and shall be uploaded by the NB and made available to the public via Eudamed (once fully operational).

The Summary of Safety and Clinical Performance (SSCP) should be updated with clinical data from the Post-Market Clinical Follow-up (PMCF) or Periodic Safety Update Report (PSUR) at least annually. If necessary, updates should occur sooner.

For further guidance see MDCG 2019-9.

CLINICAL EVALUATION CONSULTATION PROCEDURE (CECP) AND ARTICLE 54

A CECP will be mandatory in cases when performing a conformity assessment of certain high-risk devices. A CECP (MDR Article 54.1) is applicable for class III implantable and IIb active devices intended to administer and/or remove a medicinal product according to Rule 12, unless article 54.2 can be applied.

Here, an independent panel of experts in the particular medical field will provide a scientific opinion.

For further guidance see MDCG 2019-3.

FAQs

• Which medical devices require a clinical evaluation?
  • All medical devices require a clinical evaluation regardless of their classification. 

• Which documents will be reviewed by the notified body concerning the clinical evaluation? 
  • The evidence that needs to be provided contains the following main documents: clinical evaluation plan, the clinical evaluation report, literature plan and report, clinical investigation plan, clinical investigation report, risk management documents, SSCP, IFU, PMCF plan and report, PMS plan, PSUR. This list is not exhaustive.
• What shall an appropriate clinical evaluation report include?
  • Please refer to MDR Art 61, MDR Annex XIV part A, and MDCG 2020-13.