From planning to authorisation: clinical evaluation of medical devices ‍

If you want to launch a new medical device on the market as a manufacturer, there are demanding legal requirements to fulfil. The most important information regarding the clinical evaluation of medical devices is summarised for you below.

What is a clinical evaluation?

Before a medical device is placed on the market, manufacturers must demonstrate its performance, safety and clinical benefit.

A clinical evaluation (Article 61 and Annex XIV, see p. 164 MDR), thus, is carried out for this purpose.

The clinical evaluation can be based on objective data from the specialised literature or results from previous clinical trials.

These must be analysed and evaluated. The clinical evaluation is part of the technical documentation as part of the conformity assessment procedure for obtaining the CE mark and must be updated regularly after market launch. The clinical evaluation is therefore part of the quality management system and closely linked to risk management.

Legal basis

The content of a clinical evaluation is regulated by laws and standards. The former Medical Device Directive (MDD) was superseded by the new EU Medical Device Regulation (MDR), also referred to as the European Medical Device Regulation, on May 26, 2021. This introduces substantially more demanding requirements. Concurrently, in Germany, the Medical Devices Act (MPG) was replaced by the Medical Devices Implementation Act (MPDG).

Processes for the clinical evaluation of medical devices over the entire product life cycle.

Sources: MDR (2017/745), MDCG 2020-1, MDCG 2020-5, MDCG 2020-6, MDCG 2020-13, MEDDEV 2.7/1 revision 4 (June 2016)

What is clinical performance?

The clinical performance refers to the ability of a product to achieve its intended purpose, as specified by the manufacturer, resulting from its technical or functional characteristics, including diagnostic features, and all direct or indirect medical effects, such that when used as intended by the manufacturer, a clinical benefit for patients is achieved.

What is the clinical benefit?

The clinical benefit, as referred to in Article 62(1)b), is a positive impact of a product on a person's health, demonstrated by meaningful, measurable, and patient-relevant clinical outcomes, including diagnostic results, or a positive impact on patient management or public health. Similarly, the term 'medical benefit' (as referred to in §139 SGB) is to be understood in a comparable manner.

How should you proceed?

Phase 1: Planning

• Description of the objective and structure of the clinical evaluation
• Classification of the product: Is it a known or new technology/application?
• Definition of the intended use
• Creating a target product profile if necessary

We are happy to support you from the very beginning and help you to complete the scientific evidence for your medical device on time.

Phase 2: Identification of suitable data sources

• Scientific literature
• Available clinical data, comparison with other products if applicable
• Clinical experience
• If not derivable: Generation of new or additional clinical data based on a clinical investigation (for requirements see Annex XV, p. 167 MDR) in accordance with the Clinical Evaluation Plan (CEP; see Annex XIV)

We conduct systematic literature searches based on internationally recognised scientific standards - we act quickly and effectively. Just get in touch with us!

Phase 3: Analysing and evaluating the data

• Evaluation based on pre-defined criteria
• Evaluation of individual data sources: qualitative and quantitative analysis
• Systematic evaluation of the scientific literature
• Overall evaluation of the relevant data to assess whether there is evidence of the performance and safety of the medical device
• Comparison with other products

Phase 4: Reporting (Clinical Evaluation Report)

The clinical investigation report is a comprehensive document that describes the planning, conduct, analysis, and results of a clinical investigation of a medical device. This report must comply with the requirements of ISO 14155 in its current form, the Medical Devices Implementation Act (MPDG), and the EU Medical Device Regulation (MDR). It must be detailed and comprehensive to meet the requirements of ISO 14155:2020, the MDR, and the MPDG. The report serves not only to document the scientific and clinical results but also to ensure compliance with regulatory requirements and the credibility of the entire endeavour.

Phase 5: Post-market surveillance (see Annex XIV, Part B)

• Periodic safety update report (PSUR; see Article 86)
• Trend reporting (see Article 88 MDR)
• Results of market monitoring incl. corrective actions
• Total sales volume and estimate of the number of users

A thorough clinical evaluation lays the foundation for the safety and effectiveness of your medical device. MEDIACC is at your side to provide scientific evidence as part of a suitable clinical investigation or study and to achieve market authorisation.

(as of spring 2018)

Can we support you too? You are welcome to arrange a first non-binding consultation here.