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EU Medical Devices Regulation

Medical Devices in the EU are regulated by the Medical Device Regulation (MDR) that replaces both the Medical Device Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD), coming into full application in May 2021, with a translational period for certain medical devices until May 2024. 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)

  • 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.

  • For medical devices to be certified, a Quality Management System (QMS) must be implemented. Many companies use the ISO13485 in their QMS implementation since it is the only QMS standard on the EU harmonized list.

  • More robust clinical evaluation will be conducted to strengthen pre-market approval of higher risk medical devices.

  • 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).

  • In the new life-cycle approach, there will be requirements relating to post-market surveillance, market surveillance, vigilance, and the registration of economic operators and devices.

Scope and definition of medical devices

  • ‘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:

    • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

    • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

    • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

    • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

  • Including:

    • products specifically intended for the cleaning, disinfection or sterilization of devices

    • 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:

    • Class I: Lowest risk, non-sterile devices, or devices without a measurement function can be self-certified.

    • Class I (Special Function): Low to medium risk, sterile devices, devices with a measurement function, invasive devices for transient use, or non-invasive devices that do not fit into other classes.

    • Class IIa: Medium risk, invasive devices for short-term use.

    • Class IIb: Medium to high risk, invasive devices for long-term use.

    • Class III: Implantable devices for long-term use.

Brief Regulatory Process flow for Medical Devices to obtain a CE mark in Europe

  1. Appoint a "Person Responsible" for regulatory compliance

  2. Implement a Quality Management System (QMS) that includes Clinical Evaluation, Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) plans

  3. Prepare a CE Technical File or Design Dossier (for Class III). The files should include the following not exhaustive items; information about the device, intended use, test reports, clinical evaluation report, risk management plan, IFU, labeling and Unique Device Identifier..

  4. Appoint a qualified handler of regulatory issues as an Authorized Representative based in the EU.

  5. QMS and Technical File or Design Dossier to be audited by a Notified Body.

  6. Upon successful completion of the Notified Body audit, as CE Marking certificate for the device and an ISO 13485 certificate for the manufacturing facility will be issued.

  7. After a Declaration of Conformity (DoC) is prepared that states the device is in compliance with the MDR, the CE Marking may be affixed.

  8. The device and its Unique Device Identifier (UDI) shall be registered on the EUDAMED database and the UDI to be on label.

  9. A Notified Body will carry out audits annually. Clinical Evaluation, PMS and PMCF activities shall be sustained to maintain the certification. 

Reference:

[1] ec.europa

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