Digital Health: CE marking of medical devices In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the #medicaldevices directives. These directives provide the basic definition of a medical device and lay down the technical and procedural obligations that must be followed by the manufacturer of a medical device prior to affixing a CE mark to the product.
For all medical devices, whether standalone software or otherwise, the medical devices directives provide that the product cannot be used or marketed in the EU unless a CE mark has been validly affixed to it in accordance with the provisions of the applicable EU legislation. For some medical devices, essentially those falling within Class I and those regulated as in vitro diagnostic medical devices, a self-assessment process and a related Declaration of Conformity by the manufacturer is sufficient. For other medical devices, including devices considered to be medium or high-risk medical devices such as Class IIa, Class IIb and Class III medical devices, a “notified body” must undertake an assessment of the conformity of the manufacturer and/or the device in accordance with the applicable provisions of the relevant directive. Manufacturers of digital health technologies such as medical apps or wearable sensors must now also consider the new rules and obligations laid down in the Medical Devices Regulation (“MDR”) and the In Vitro Diagnostic Regulation (“IVDR”) which were adopted by the European Parliament and the Council in May 2017. Among other things, the MDR which will apply from 26 May 2020, introduces new classification rules for medical devices software. These new classification rules will significantly affect software currently regulated as Class I medical devices in the EU. To get a proper guidance on the CE marking of medical devices, we specialize in providing consultancy & regulatory assistance for Medical Device manufacturing plant layout, primary packaging, licenses, certifications, compliances, import and exports paper work to more the 125 countries. Hence, we ensure the hassles of regulatory bodies are expertly taken care off. For further enquiry, Contact Us on, Email-id: info@operonstrategist.com, anilmchaudhari@gmail.com Contact No: +91-9028043428, +020-65283428 Website: http://www.operonstrategist.com/
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Medical Device Manufacturing Regulatory Consultant: Operon Strategist