Fundamentals, tools and usable data

Lukas Losigkeit - Clinical evaluation plan - clinical evaluation report - For MDR medical devices

Lukas Losigkeit

CEO & Principal Consultant

In part 1 of our blog series on clinical evaluations we have already dealt with the following questions:

  • Why are clinical evaluations so complex?
  • When should the CER be created?
  • Which documents should be created?
  • When should the CER be updated?
  • Is training necessary?

In today's article, the second part, we will go into this topic in more detail and prepare you to create a clinical evaluation.

Before you start with the clinical evaluation, you should first think about how you want to set it up. Which requirements do you have to implement? Which tools are available? What is the data basis on which you are building the clinical evaluation?

These considerations are very basic, but essential. We recommend to start with them before you start with the actual planning, the "CEP - Clinical Evaluation Plan".

Guidance on the clinical evaluation of medical devices

What are the fundamentals and tools?

At this point, we will concentrate exclusively on clinical evaluations that are to be prepared in accordance with the EU 2017/745 (MDR). The MDD therefore does not appear here.

  • MDR EU 2017/745
  • MEDDEV 2.7-1 rev. 4 (MDCG 2020 – 6 shows which chapters are still valid)
  • 05 MDCG 2020-5 Guidance on Clinical Evaluation – Equivalence
  • 06 MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices

As you may have noticed, MEDDEV 2.7-1 Revision 4 refers to the MDD, which is not really part of the discussion. So what is the purpose of the document here?

MEDDEV provides an established and well-functioning structure for the preparation of clinical evaluations. Many of the contents are still valid and should therefore be taken into account. However, attention should be paid to the differences to MDR. Helpful in this context is, for example, the "MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices". In this document, Annex I describes which areas of the MEDDEV are still relevant under MDR.

In addition, the MDCG 2020-6 provides important information on how to realize a clinical evaluation according to MDR with some products already approved under the MDD.

The "05 MDCG 2020-5 Guidance on Clinical Evaluation - Equivalence" basically describes the procedure in a clinical evaluation according to MDR in which clinical data of equivalent products are to be used. This is because it requires proof that the products are truly equivalent. The guidance provides comparison parameters that should be used.

Of course, the actual basis is MDR. Compared to the MDD, the requirements for clinical evaluation are formulated in much more detail. This is not necessarily bad, because it shows more clearly what is expected.

As a small hint: Use the guidelines provided. Do not reinvent the wheel! We strongly advise you to read these documents in detail and follow them during the clinical evaluation.

Which data should be used for the clinical evaluation?

There are different data that can be used in the clinical evaluation. The regular approach is to use clinical data on your own product and, where appropriate, equivalent products.

There is a possibility in MDR for exceptional cases where compliance with the General Safety and Performance Requirements (GSPRs) cannot be proven through clinical data. This is described in Article 61, paragraph 10. However, this is really only possible in a few cases and must be argued in the context of risk management and taking into account the device itself.

The following data can be used, for example:

  • Clinical investigations carried out by the manufacturer
  • Published clinical investigations in which the own product was used
  • Published clinical investigations in which an equivalent product has been used (equivalent products are products that are biologically, technically and clinically equivalent to the own product)
  • Post-market surveillance data
  • Post-market clinical follow-up data
  • Non-clinical data approach according to Article 61, paragraph 10 of the MDR

Is your product already registered under the MDD or AIMDD?

Then take a look at "MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices". This document is a blessing for so-called Legacy Devices! In other words, products that were / are approved under the MDD or AIMDD.

As part of the guidance, you should especially check whether your product meets the requirements for a product with "well-established technology". For this purpose your product must meet these requirements:

  • Relatively simple, common and stable designs with little development
  • The generic product group has known safety and has not been associated with safety problems in the past
  • Well-known clinical features and their generic product groups are standard care devices for which the indications and the state of the art have developed only slightly
  • Be available on the market for a long time

Next steps

You now already have an idea of the basics and tools you can use in clinical evaluation. Especially with regard to legacy devices there is very useful guidance. The next step is to identify equivalent products. We will explain what you need to consider in the next blog post. Thank you very much for your attention!