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Clinical Impact of the new EU legislation on medical devices Danielle Giroud
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- That Europe is trying strenghten the clinical data requirements.
- That the regulators look beyond performance into the clinical benefit for patients inline with what the medical community is looking for
- That Notified Bodies will be focusing more in clinical evaluation and work on their knowledge and understanding thereof
- That we move towards a better enforcement.
It is about time
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- Avoid further confusion? - Avoid a total mix up between the pharma and
the device approach? - Get the terminology defined right, before we go
further? - Ensure there is a true training of notified body
auditors on clinical evaluation? - Work together rather than reinventing the wheel
and create inconsistencies with existing guidance documents?
Should we not… Really?
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- Better enforcements of the already existing requirements for clinical evaluation.
- Class III are mostly targeted - Need for annual update of clinical evaluation
report for class III and implantable devices - Most likely a simplified safety reporting system
during pre-market clinical investigations
What is likely?
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- Enforcement of PMCFU e.g. - …Manufacturers should report periodically on
medical devices classified as Class III as regards the data relevant to the risk benefit ratio and the exposition of the population in order to evaluate whether any action concerning the medical device concerned is necessary…
What is likely?
Difficult to establish without a proper prospective data collection
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What is not clear yet?
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What is not clear yet? - We find a mix of performance and clinical
performance, of benefits and clinical benefits.
- Clinical investigations for medical devices where made compulsory in accordance with this Regulation, shall include clinical investigations in the appropriate target population and well controlled investigation
Corresponding to the intended use
Well designed? Well conducted? … why not well GCP?
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What is not clear yet? - Who is the Assessment Committee for Medical
Devices (ACMD)?… shall provide an opinion on the robustness of the clinical data by way on an assessment in specific cases
Should manufacturers seek consultation to avoid surprises?
Which cases? Clear enough defined?
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What is not clear yet? - Sponsors should submit results of a clinical
investigation together with a layperson summary ….
- The commission should provide guidelines for managing and facilitating the sharing of raw data from all clinical investigations.
Even if results are not good! How else to create public panick?
What for? Are notified body audits not sufficient?
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What is not clear yet? - Sponsors should report (certain) adverse events
occurring during clinical investigations… - Such information shall be communicated to the
other Member States, the MDCG and the Commission.
Does the writer realises the consequences? I believe they mean SADE here only.
That’s going to create a load of officer jobs!
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Reinventing the wheel? - Several definitions are re-invented without really
clear evidence why e.g. - Fœtal distress, fœtal death or a congenital,
physical or mental impairments or birth defect?
Does not make it much clearer?
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Reinventing the wheel? - In depth sections on how ethics committees
should operate including their basis of review. - E.g. The commission shall develop guidelines on
patient involvement in ethics committees, drawing upon existing good practices….
Really the commissions’ responsibility?
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Clinical Investigations - Prospective clinical data for all Class III devices - ‘Effectiveness’ will bring more randomized study
designs regardless the classification. - Current wording ‘clinical performance study’ not
yet defined – no provision of pilot investigations not yet looking for clinical performance or effectiveness
- Guidance on product specific clinical data requirements
- Cardiology - Orthopedics - Etc
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Clinical Investigations - In Vitro Diagnostics
- Performance evaluation studies will become more frequently required
- Interventional studies compared to in vitro studies – increased GCP requirements
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Clinical Investigations - The notification process
Step I: submit to memberstates Step II: memberstates acknowledgement Step III: review and response (approval or rejection - list of reviewers should be made available to the Sponsor!
14 or 20 days
60 days
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Clinical Investigations - The notification process for multicentre clinical
investigation: - Voluntary centralised notification in case of
EU multinational clinical investigation. - Unclear how this will avoid duplicate
notifications i.e. centralised and to the national authorities
- Seems centralised SADE reporting will only be possible if the sponsor has done a voluntary centralised submission (37)
- Need to appoint coordinating Member State
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Clinical Investigations - EUDAMED data base:
- Will it be ready? - Who will do what?
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Clinical Investigations - Regulatory documents update
- MEDDEV 2.7.1, 2 and 3 will need update to align with new regulation and give better guidance to both regulators, notified bodies and industry
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Clinical Investigations - Regulatory documents update
- ISO 14155:2011 – start of new revision in Jan 2014
- Introduce Effectiveness? - More detail on risk analysis - Clinical investigation design more
elaborate guidance - Registry studies – more support for
PMCFU - Expand for IVD?
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Conclusion - More clinical investigation require more resources
- GCP qualified people - Improved knowledge on clinical evaluation of
regulatory professionals mandatory by the new legislation
- Financial resources - Enforcement of increased scrutiny by notified
bodies - Need better understanding of clinical
evaluations and GCP - NBOG clinical evaluation check-list needs
revision
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Conclusion - Yet a lot of unclear and ambiguous wording. - Many more definitions are needed
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Conclusion - Definitely more clinical investigations
- Definitely more complex design for clinical investigations
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Conclusion
- The rest is still speculation…
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