Medical Devices - Europe
Compliance Services
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Background Information
Medical Devices in the EU are regulated by the Medical Device Regulation (MDR) 2017/745 that replaced Medical Device Directive (MDD) 94/32/EEC come into full application in May 2021.
A new extended transition period for certain legacy medical devices until Dec 2028 was issued under Regulation (EU) 2023/607 in March 2023. All medical devices must comply with the MDR in order to obtain a CE marking certification and be sold on the EU market.
Medical Device Regulation (MDR)
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Revised the laws governing medical devices to ensure a robust, transparent and sustainable regulatory framework and maintain a high level of safety, while supporting innovation. The new regulation takes on a life-cycle approach to medical device regulation instead of the previous directives which are more focused on the pre-approval stage of medical device manufacturing.
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For medical devices to be certified, a Quality Management System (QMS) must be implemented. Many companies use the ISO 13485 in their QMS implementation since it is the only QMS standard on the EU harmonized list.
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More robust clinical evaluation will be conducted to strengthen pre-market approval of higher risk medical devices.
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To improve the traceability of medical devices a unique device identification (UDI) shall also be implemented, and information on devices and studies being made public such as on the European Database for Medical Devices (EUDAMED).
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Manufacturers has to comply with ISO 20417 Medical Devices- Information to be supplied by the manufacturer.
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In the new life-cycle approach, there will be requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices.
Definition of Medical Device
‘Medical device’ is defined as any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
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Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
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Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability.
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Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state.
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Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.
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Products specifically intended for the cleaning, disinfection or sterilization of devices
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Devices for the control or support of conception.
Medical Device Classification
The MDR has laid out 22 rules to determine the risk classification of medical devices into the following 4 groups:
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Class I: Lowest risk, non-sterile devices, or devices without a measurement function can be self-certified.
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Class I (With Special Function): Low to medium risk, sterile devices (Class 1s), devices with a measurement function (Class 1m), reusable surgical instruments (Class 1r)
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Class IIa: Medium risk, invasive devices for short-term use.
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Class IIb: Medium to high risk, invasive devices for long-term use.
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Class III: Implantable devices for long-term use.
Summary Process of Medical Devices to obtain a CE mark in Europe
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Determine medical device classification.
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Appoint a "Person Responsible for Regulatory Compliance” (PRRC).
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Implement a Quality Management System that includes Clinical Evaluation, Risk Management, Post-Market Surveillance (PMS) and assignment of Unique Device Identification (UDI).
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Prepare a Technical Documentation. Requirements shall refer to EU MDR Annex II and III.
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System to manage critical supplier.
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Conduct a Clinical Evaluation.
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Appoint an Authorized Representative based in the EU (for foreign manufacturer).
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QMS certification audit and Technical Documents review by a Notified Body.
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Preparation of Declaration of Conformity (DoC) after certified with MDR.
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Purchase, assign and register device Unique Device Identification (UDI) on EUDAMED.
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Affix CE Marking to the medical device.
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Actively maintain Post-Market Surveillance activities and preparation for annual audit.