Educational material

Clinical Data

When a medical device is CE marked, this means a declaration by the manufacturer that the device performs as indicated by the manufacturer and the device's clinical benefits are not in disproportion to its side effects when used for its intended purpose and in the prescribed manner.

The supporting documentation for this declaration must include a clinical evaluation. The evaluation must be based on clinical data (see below) that can be retrieved from the relevant scientific literature and/or from clinical investigations.

Clinical investigation

Clinical investigations are only to be performed when the necessary information on the performance, safety, and clinical benefit of the device cannot be obtained in any way other than by testing the device on humans. A clinical investigation may be necessary regardless of the risk classification of the device.

For implants and products with risk classification III a clinical investigation must be performed.

The responsibility of the manufacturer

A manufacturer must be able to demonstrate that the devices placed on the market are safe and have the properties listed on the device label, or in other materials provided by the manufacturer. This also applies to claims made in sales materials and pledges made by representatives/sellers. This responsibility is detailed in the Act.

Act 1993:584 on medical devices:

Section 5; A medical device must be suitable for its intended use.

The device is suitable when it:

1. is correctly delivered and installed, and maintained and used in accordance with the manufacturer's labelling, instructions or marketing, and
2. achieves the performance intended by the manufacturer and meets the high requirements for the protection of the lives, personal safety and the health of patients, users and others.

Swedish Medical Products Agency (Swedish MPA) further elaborates this in the provisions issued in connection with the Act on medical devices:

• Appendix 1 about the essential requirements of the Swedish MPA regulations LVFS 2003:11 on medical devices in particular paragraphs 1, 3, 4, 5 and 6.
• Appendix 1 of the Swedish MPA regulations LVFS 2001:5 on active implantable medical devices, in particular paragraphs 1, 2, 3, 4 and 5.

LVFS 2003:11:

LVFS 2001:5:

In order to meet these requirements, the manufacturer must have sound knowledge of how the device will work in practical use, in other words the manufacturer must have knowledge of the device's characteristics and actual performance. In particular, the manufacturer must know what unwanted side effects the device might cause.

This knowledge is termed “clinical data” and serves as important supporting documentation for the clinical evaluation that will provide answers to the question about whether the device's risks outweigh its benefits.

To generate the necessary clinical data
Basically there are three options:

1. A critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose, where
   • there is demonstration of equivalence of the device to which the data relates, and
   • the data adequately demonstrates compliance with the relevant essential requirements,
2. a critical evaluation of the results of all clinical investigations made, or
3. a critical evaluation of the combined clinical data provided in 1 and 2.

Guidance on clinical evaluation and clinical data compilation and evaluation

 Guidance on clinical evaluation according to MDR

In the new EU regulation on medical devices (2017/745, MDR) there are regulations on clinical evaluation in article 61 and appendix XIV.

Investigator

Terminology for investigators

The Swedish MPA applies the terminology included in the standard SS-EN ISO 14155:2020:

Principal investigator

Qualified person responsible for conducting the clinical investigation at an investigation site.

If a clinical investigation is conducted by a team of individuals at an investigation site, the principal investigator is responsible for leading the team.

Investigator

Individual member of the investigation site team designated and supervised by the principal investigator at an investigation site to perform critical clinical investigation-related procedures or to make important clinical investigation-related decisions.

Coordinating investigator

Investigator who is appointed by the sponsor to coordinate work in a multicenter clinical investigation.

Who can be appointed as principal investigator?

The principal investigator at each investigation site should be a person who practice a profession that makes the person qualified for the role as an investigator and have proper scientific background and patient care experience.

Other personnel who participate in the conduction of the clinical trial should have appropriate qualifications to perform their duties, in form of education or experience within the medical field in question and within clinical trial methodology.

The responsibility for the medical care provided to the subjects resides with:

• a medical doctor with appropriate qualifications or
• a qualified dentist or
• other person who is entitled by national law to provide the relevant patient care under clinical investigation conditions.

The Swedish MPA assesses if the principal investigator has appropriate qualifications for the clinical investigation. Based on the study design, there might be a need to involve additional persons in the investigation to ensure sufficient medical oversight. A current CV or other documentation for those persons may need to be submitted.

Requirements regarding qualifications of principal investigators are described in the standard SS-EN ISO 14155:2020, section 10.2. Additional information on the general requirements for appropriate qualifications and the sponsor’s responsibility to select principal investigators and ensure they have adequate knowledge to conduct the investigation is provided in sections 6.1 and 9.2.1.