You can do much of this yourself
The rules are public. So is much of the guidance.
A good evidence strategy normally starts by working from the regulatory requirement towards the study, rather than starting with a study and trying to justify it afterwards.
1. Start with the regulation
For a medical device, look at MDR Article 61 and Annex XIV on clinical evaluation.
For an IVD, start with IVDR Article 56 and Annex XIII. The IVDR structures performance evaluation around three questions:
- Is there scientific validity?
- Does the device perform analytically?
- Does it perform clinically for its intended purpose?
Those questions should determine what evidence you need.
2. Check the MDCG guidance
The European Commission maintains a searchable collection of MDCG guidance explaining how the MDR and IVDR are applied in practice.
Some particularly useful starting points are:
- MDCG 2020-1 for clinical or performance evaluation of medical device software
- MDCG 2022-2 for clinical evidence for IVDs
- MDCG 2020-5 when relying on equivalence
- MDCG 2020-7 and 2020-8 for post-market clinical follow-up planning and reporting
Not every document will apply to every product. The point is to find the guidance that relates to the claim, technology and evidence question you are dealing with.
3. Find the relevant standards
Standards provide established methods for many parts of verification and validation.
Depending on the device, useful examples include:
- ISO 14971 for risk management
- IEC 62304 for medical device software lifecycle processes
- IEC 62366-1 for usability engineering
- ISO 14155 for clinical investigations of medical devices
- ISO 20916 for clinical performance studies of IVDs
- IEC 81001-5-1 for cybersecurity activities in the health software lifecycle
For IVD analytical performance, CLSI guidelines are also an important source of established study methods. They cover questions such as precision, linearity, interference, method comparison and detection capability.
The European Commission publishes the current lists of harmonised standards under the MDR and IVDR. MDCG 2021-5 also explains how standards, harmonised standards and state of the art fit into the regulatory framework.
4. Work backwards from the claim
Before commissioning a test, validation exercise or clinical study, ask:
- What claim does this evidence support?
- Which regulatory or safety requirement does it address?
- What characteristic are we trying to demonstrate?
- What would constitute an acceptable result?
- Why is this method appropriate?
- How much evidence is enough to support the conclusion?
If those questions cannot be answered, it may be too early to run the study.
Where Fabola comes in
The difficult part is rarely finding another guidance document.
It is deciding which requirements actually apply, what evidence is already available, where the genuine gaps are, and what level of evidence is proportionate.
We help manufacturers build that chain from:
intended purpose → claims → risks → requirements → evidence → acceptance criteria
The result should be evidence that is scientifically credible and regulatorily defensible, without generating studies simply because they feel reassuring.