Wearables / Connected Devices | MedTech Compliance Guide

EU requirements

Classification: MDR Rules 10, 11, or 13 may apply: active diagnostic or monitoring devices use Rule 10, decision-support software Rule 11, and other active devices Rule 13 (default Class I). Vital-parameter monitoring with immediate-danger risk is Class IIb. Wellness or fitness products without medical intended purpose are outside MDR scope.
Conformity pathway: Class I devices may be self-declared; Class IIa and IIb devices require a Notified Body assessment under Annex IX.

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01Determine whether the intended purpose is medical and in scope, or general wellness and out of scope; document the rationale.
02Classify under Rule 10, 11, or 13.Source: MDR 2017/745 Annex VIII
03Apply IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2 EMC testing where applicable.
04Implement an IEC 62304 software lifecycle.
05Conduct IEC 62366-1 usability engineering and ISO 14971 risk management.
06Prepare a Clinical Evaluation Report and assign a UDI when in scope.

Classification: Low-risk wellness devices may be Class I, exempt, or within General Wellness enforcement discretion. Medical monitoring or diagnostic claims commonly lead to Class II classification.
Conformity pathway: Wellness-only products may fall within General Wellness enforcement discretion. A diagnostic or therapeutic claim can require 510(k) for Class II or De Novo for a novel device.

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01Determine eligibility for General Wellness enforcement discretion versus the need for a premarket submission.Source: FDA General Wellness Policy
02If making a medical claim, determine the 510(k) predicate or De Novo need.Source: FDA De Novo overview
03Conduct IEC 60601-1, IEC 60601-1-11, and IEC 62304 verification and validation.
04Prepare cybersecurity documentation under FDA premarket cybersecurity guidance.
05Establish a DHF and QMSR-aligned quality system.Source: FDA QMSR