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Medical Devices

 

CE Mark (Conformité Européenne - European Conformity)

Devices that are intended to be used for medical purposes are  required to be CE marked under MDR (EU) 2017/745 and In vitro diagnostic products under the regulation IVDR (EU) 2017/746. MDR introduces a life-cycle approach to ongoing CE Marking compliance. 

The CE mark shows that the device is fit for its intended purpose stated and meets legislation relating to safety. It shows the product can be freely marketed anywhere in the European Union (27 member states of the EU and EFTA countries, Iceland, Norway and Liechtenstein).

The European Commission’s website has more information on CE marking.

EUDRAC supports its clients in obtaining or maintaining CE Mark Registration for its medical devices.

We work on the development of new medical devices and then oversee the QMS and maintenance of Technical Files throughout the lifecycle of a device.

  • We work alongside our clients as they develop new medical devices, liaising with Notified Bodies, preparing Technical File documentation and Product life cycle plan. We also collaborate in the development of the required Quality Management System, as well as Post-market surveillance.
  • For devices that have CE mark registration, EUDRAC provide device vigilance and ongoing review of the QMS and Technical File.
  • For clients who obtain a registered medical device from another manufacturer, we undertake the full transfer process required for the CE mark.  

Borderline Products

A borderline product is one for which it is not immediately clear as to whether it falls under the Medical Device legislation or Medicinal Product legislation.  A product cannot fall under both sets of legislation.  In order to be classified as a Medical Device it must meet the legal definition of a device and must also not be excluded from the scope of the Medical Device legislation.

How can we help?

EUDRAC provides regulatory advice on the classification of borderline products. We liaise with National Competent Authorities and Notified Bodies and will establish the correct regulatory procedure for your product. 

EUDRAC has experience in working with borderline products in a number of different therapeutic areas. We establish suitable medical claims for a product and the correct conformity assessment route for those products which comply with the criteria for Medical Devices.

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  • Virtual Manufacturers

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    The EU has now significantly increased the requirements for manufacturers who place their name on Medical Devices for which the design and production is outsourced.  This process is known as “Virtual Manufacturing” (formerly “Own Brand Labelling”).  Such manufacturers must now:

    • Have their own QMS audited by Notified Bodies
    • Have full Technical Documentation for the relevant medical devices

     

    How can we help?

    EUDRAC reviews and updates “summary technical documentation” to meet the full technical documentation now required for these medical devices; we also ensure our clients QMS will meet the required standards and liaise with the Notified Body throughout the audit procedure.  Please refer to our Case Study on “Virtual Manufacturers”.  

  • Clinical Investigations

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    All clinical investigations of new medical devices must be approved by the National Competent Authority of each country in which the investigation is to be conducted. This approval procedure is conducted on a national basis.

    How can we help?

    EUDRAC assists its clients with the submission and notifications of clinical investigations in both EU Member States and other regions via our network of Partners.  We also adapt the Clinical Investigation Plan to meet the specific national requirements and liaise with the NCA throughout the approval procedure.

    Currently we are working with clients who are conducting clinical investigations of new medicinal products and new delivery devices for which the clinical investigation must meet the requirements for both drug and device.

Technical Files

A Medical Device Technical File includes all information on the device required to demonstrate compliance with EU requirements for a CE mark. It is required for all classes of Medical Devices and is unique to the individual device or group of devices.

How can we help?

EUDRAC work with our clients throughout the development of a device and compile technical documentation to support CE-certification. We liaise with Notified Bodies and participate in audits throughout the lifecycle of a device.  

EUDRAC construct and review all parts of a Technical File for a medical devices according to its relevant Conformity Assessment Route.  

  • As the new Medical Device Regulations come into force we are updating our clients’ documentation to comply with the additional requirements. 
  • We perform annual reviews of Risk Assessments and updates according to post-marketing vigilance and surveillance data.

 

Quality Management System (QMS)

Quality Management Systems, Standard Operating Procedures and Work Instructions are all necessary to ensure that an organisation operates in compliance with Medical Device requirements. Due to the strict regulatory nature of the industry, best practices need to be established, documented and implemented.

How can we help?

EUDRAC works with clients to develop a Quality Management System to support the CE-registration of their medical device portfolio. We also review the QMS when a client develops a new device and provide the support needed for any changes that need to be implemented.

EUDRAC works with our clients throughout the development of new devices to ensure their QMS comply with the relevant regulatory requirements. We also provide support in the preparation for Notified Body audits; we oversee our clients’ QMS throughout the marketing of their medical devices.

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  • Device vigilance

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    The purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, healthcare professionals, and other users by reducing the likelihood of reoccurrence of incidents related to the use of a medical device.

    The Medical Devices Regulation MDR (EU) 2017/745 and In-Vitro Diagnostic Regulation IVDR (EU) 2017/746 state that adverse incidents are evaluated and, where appropriate, information is provided to National Competent Authorities.

    How can we help?

    EUDRAC works with its clients in the planning and implementation of device vigilance that meet the Conformity Assessment requirements.

    EUDRAC will set-up and provide the full device vigilance system, or work with our clients to ensure their own systems are suitable for their medical device portfolios. We review and update the Clinical Evaluation and Risk Analysis within the Technical File taking into account any new safety data.

  • Audits & Inspections

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    The majority of compliance activities are initiated and resolved in writing, however, it may be necessary for competent authorities to inspect medical device producer sites

    Under the Medical Devices Regulation MDR (EU) 2017/745, national competent authorities can issue:

    • A compliance notice to formally outline perceived offences and request you to correct a non-compliance
    • A restriction notice, in order to restrict the availability of a particular medical device, or of devices of a particular class or description.

    Audits provide an objective evaluation or an organisation’s system. Good audits will provide an accurate measurement of the implementation of an organisation’s system against its procedures and the applicable legal requirements. They are a vital part of the Quality Management System (QMS) of an organisation.

    How can we help?

    EUDRAC provide a full audit service for medical devices.  We also work alongside our clients in the development of their QMS and the CE-mark registration of their devices; we liaise with the Notified Bodies during inspections and any follow-up procedures.

    EUDRAC conduct audits of our clients QMS and Technical Documentation.  We work with our clients to prepare them for Notified Inspections.

     

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