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.
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.
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.
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:
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”.
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.
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.
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.
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.
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.
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.
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.
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.
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:
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.
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.