Check These Important Information You Should Consider Before Claiming Equivalence Under MDR
HATEM RABEH, MD, MSc ing
Clinical Evaluation Expert | I help you create your clinical strategy and accelerate your Clinical Evaluation process for your medical device. Contact Me 👇
Hi Dear,
I hope you're doing well despite the busy medical device regulations!
If everything's going smoothly, you're probably just between regulatory audits. We all know the calm before the next compliance storm is short-lived! 😅
Today, I want to dive deep into one of the most critical concepts in medical device development: equivalence claims under the MDR.
Claiming equivalence has become more stringent, demanding thorough understanding and meticulous documentation. Here are the critical points to keep in mind:
1. Equivalence Criteria:
o Devices must meet specific technical, biological, and clinical criteria.
o Equivalence claims require no clinically significant differences in safety or performance.
2. Classification-Based Requirements:
o For Class III and IIb implantable devices:
o For Class IIa and IIb non-implantable devices:
3. Sufficient Access to Data:
o Manufacturers must demonstrate adequate access to clinical data for all device classifications.
o Lack of sufficient data access invalidates equivalence claims.
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4. Documentation and Justification:
o Clearly identify equivalent devices and provide detailed documentation.
o Scientific justifications are required for any differences in materials, design, or intended use.
5. Technical, Biological, and Clinical Equivalence:
o Technical: Similar deployment methods, operational principles, and performance characteristics.
o Biological: Same materials or substances, particularly critical for implantable devices.
o Clinical: Same clinical purpose, conditions of use, and user type.
6. Regulatory and Guidance Documents:
o Follow MDCG guidance, particularly MDCG 2020-5 for equivalence claims.
o Refer to Annex 14, Part A of the MDR for detailed requirements.
Feel free to share this information with your colleagues to stay updated!
Stay safe and take care.
Peace ✌️,
Hatem
Regulatory Clinical Affairs Manager
5moThank you for this detailed overview. Just one doubt about "Scientific justifications are required for any differences in materials, design, or intended use": actually, the materials in contact with the patient and the intended use must be the same, so maybe the scientific justification can be exploited to justify technical differences only. Let me know if my point makes sense to you! Thank you
Clinical Operations Manager | Medical Device & IVD Evaluation | EU MDR & IVDR Compliance | Clinical Evidence Specialist | Risk Management | Team Leadership
5moHello, thanks for the awesome update. Just a thought on the 3rd point. Sufficient access to clinical data is not always required for devices other than classes IIb implants and III. Let me know if you think otherwise.