Article 61 Clinical Evaluation in the EU MDR

Article 61 Clinical Evaluation

The MDR reinforces the clinical data and evaluation process (article 61 and Annex XIV), and the manufacturer must confirm the device’s conformity to fundamental health and safety requirements using reliable clinical data and evaluation.

The clinical evaluation establishes the device’s safety and capacity to fulfil its intended function. It also evaluates adverse side effects and determines whether the benefit-risk ratio is acceptable.

Manufacturers must plan, carry out, and document a clinical evaluation in line with Article 61 and Part A of Annex XIV.

Clinical data for the medical device are created, compiled, examined, and ultimately evaluated through a systematic and organised process called a clinical evaluation.

The Clinical Evaluation Report (CER), which the manufacturer uses to show that the medical device complies with the general safety and performance requirements specified in Annex I of the MDR, is the end result of the clinical evaluation.

The Clinical Evaluation Report (CER) is an essential component of a manufacturer’s quality management system and an essential component of the technical documentation for the medical device (MDR Article 10 (3)). It must be actively updated on a regular basis utilising information from the post-market clinical follow-up and post-market surveillance of the medical device (PMCF).

Thus, clinical evaluation is a continuous procedure throughout a medical device’s life cycle.

The Objective of Clinical Evaluation

The clinical evaluation aims to show that the medical device can be used as intended while still being safe and effective, including in terms of its clinical advantages.

The clinical evaluation can also be used to reevaluate risks and find previously overlooked hazards or dangers. The acceptability of hazards must be reevaluated by manufacturers using the most recent clinical evidence.

The objectives of the clinical examination include:

• The product’s use for its intended purpose under normal circumstances demonstrates conformity with the general safety and performance requirements listed in Annex I of the MDR
• Evaluating or excluding undesirable side effects
• Proof of the validity of the risk-benefit ratio
• Proving the makers’ medical claims.

Alternative product methods and technologies that can be used in place of the treatment being evaluated are evaluated and documented as part of the clinical study.

The clinical evaluation must ensure that the tested product is not worse than the potential substitutes. The clinical evaluation needs to describe and assess the state of the art.

When assessing state of the art, clinical benefits, safety, and performance should be taken into account. When designing and producing their products, medical device makers must take the latest technological advancements into account.

Clinical Evaluation Data

Clinical information gathered while using the medical device forms the basis of the clinical evaluation. The following are some potential sources for these:

• Clinical trial(s) conducted by the manufacturer of the medical device
• Clinical trial(s) or other research on a known similar product from the scientific literature
• Data from post-market surveillance (PMS) are clinically significant, particularly from post-market clinical follow-up (PMCF).
• Reports regarding additional clinical trials using the product under review or a comparable product that has been published in the peer-reviewed scientific literature

Manufacturers must consider preclinical data in addition to clinical data when making their clinical evaluations.

For instance, this comprises the outcomes of the following tests: Testing for biocompatibility, electrical and mechanical safety electromagnetic compatibility in accordance with IEC 60601-1-2, usability, software, animal, simulation, and laboratory testing, as well as testing for durability and stability.

For absolutely non-critical products (stand-alone software, dental drills, oral spatulas, etc.) and must be justified by the manufacturer based on risk management, in accordance with MDR Article 61 “Clinical Evaluation” Section 10.

The manufacturer’s claims, the anticipated clinical performance, and the precise interactions the device has with the human body are all taken into account in this explanation.

According to Annex II of the MDR, the manufacturer in this situation must explain in the technical documentation why they believe it is appropriate to show compliance with the general safety and performance requirements based solely on the outcomes of non-clinical test methods, including performance evaluation, technical testing, and pre-clinical evaluation.

Clinical Evaluation Plan (CEP)

A medical device’s clinical evaluation is a continuous process for developing, collecting, analysing, and evaluating clinical data. It is systematic and well-planned.

Manufacturers are required to create and update a clinical evaluation plan in accordance with Article 61 (paragraph 12) and Annex XIV Part A “Clinical Evaluation” of the MDR (CEP).

Basic ideas like the goals and format of the clinical evaluation are already stated in this strategy. The manufacturer establishes the fundamental performance and safety standards that relevant clinical data in the CEP must back up.

With detailed clinical outcome metrics, it outlines the desired clinical advantages for the patient and specifies the intended purpose, intended target groups, and explicit indications and contraindications.

A new required component of the clinical evaluation plan is a clinical development plan (CDP) for organising pertinently planned clinical trials, including a post-market clinical follow-up plan (PMCF plan).

These adjustments give clinical findings more weight. The Clinical Development Plan (CDP) explains how the manufacturer will gather new or extra clinical data through clinical trials or observational studies to solve open “gap analysis” problems at the beginning of the development phase.

Human volunteers are used in clinical trials to assess the clinical effectiveness and safety of medical equipment.

Class III Devices and Implantable Devices

Clinical investigations must always be carried out in the case of implanted devices and class III devices, with the following exceptions:

• The already marketed device has been altered by the same manufacturer, who has also shown that the altered device is equivalent to the marketed one.
• The notified body has approved of this demonstration, and the clinical assessment of the marketed device is sufficient to show that the altered device complies with the necessary safety and performance requirements.
• Additionally, there is no requirement for clinical testing for class III and implantable devices if a manufacturer can show that its product is functionally equivalent to a product that has already been marketed, provided that the notified body has approved the demonstration and the following requirements are met.
•  The two manufacturers have a contract in place that expressly grants the manufacturer of the second product full access to the technical documentation on a continuing basis, and the original device manufacturer is still in business.

Additionally, No obligation for clinical investigation for Class III and implantable devices:

• If the devices have been legitimately marketed under previous directives, the clinical evaluation is supported by enough clinical data, and they adhere to Common specifications where they are available.

Annex XIV

A clinical evaluation must be planned, continually carried out, and documented by manufacturers in order to:

Create and maintain a clinical evaluation plan,

Utilising a systematic, scientific literature study, determine the clinical data that is available that is pertinent to the device and its intended use, as well as any gaps in the clinical evidence;

Evaluate each relevant clinical study’s applicability for proving the device’s performance and safety;

To produce any additional or new clinical data required to address unresolved problems through adequately conducted clinical research in accordance with the clinical development strategy; and

In order to conclude the safety and clinical performance of the device, including its clinical advantages, all pertinent clinical data must be examined.

Equivalence

Equivalence for the EU MDR clinical evaluation must be proven in two distinct ways.

Clinical

• Used for the same clinical condition (with equivalent severity and stage of disease).
• Utilised for the same medicinal purpose, and utilised for the same intended purposes, and
• Utilised at the same body location, and used in a population with similar features (e.g., age, gender, anatomy, physiology, etc.), and not anticipated to produce noticeably differing performances (in the relevant critical performances such as the expected clinical effect, the specific intended purpose, the duration of use, etc.).

Technical

• Have similar specifications and properties (e.g., physicochemical properties such as type and intensity of energy, tensile strength, viscosity, surface characteristics, wavelength, surface texture, porosity, particle size, nanotechnology, specific mass, atomic inclusions such as nitrocarburising, oxidability),
• Similar design
• Used under the same conditions, similar deployment methods (if applicable), and similar operating principles).

Biological

• Use the same tools or substances when in contact with the same body fluids or human tissues.

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