Tag Archives: #MedicalDevice

EUDAMED – European Database for Medical Devices

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Background

According to European Commission a web-based portal EUDAMED is being developed to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. The system consists data on medical devices that have been collected and registered by Competent Authorities and the European Commission and can only be accessed by these same parties. The amount of data which will be available to the European Authorities through EUDAMED is the most significant changes being introduced by the new European Union Medical Device Regulations (EU MDR) Article 33. This data collection with EUDAMED was established by the Medical Device Directive (MDD) Article 14a. But the amount of data made available to the European Authorities has been minimal compared to what is envisaged in the new EU MDR. This ‘MDR EUDAMED’ is intended to provide more data, of higher quality and with a wider accessibility. EUDAMED aims at improving transparency and coordination of information regarding medical devices available on the EU market.

Database Access

The ‘MDR EUDAMED’ will not only be used by the National Competent Authorities (NCAs) and the European Commission. Depending on the type of user, only certain levels of the databank can be accessed. It will also be accessed by:

  • Medical Devices Coordination Group (MDCG)
  • Notified Bodies (NBs)
  • Economic Operators (EOs – manufacturers, authorized representatives, importers, sponsors)
  • Experts
  • Non-European Competent Authorities (NCAs)
  • And the public, including medical institutions and the press

Database Module

EUDAMED will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and will be interoperable. EUDAMED is structured around 6 interconnected modules and a public website:

  • Actors ((NCA’s, EOs, NB’s) registration
  • UDI/Devices registration
  • Notified Bodies and Certificates
  • Clinical Investigations and performance studies
  • Vigilance and post-market surveillance
  • Market Surveillance

One of the key objectives of the Medical Devices Regulation (MDR) is transparency aiming at providing a larger access to relevant information to the public and strengthening public and patient confidence in the safety of medical devices placed on the EU market. These obligations in MDR will be applicable once the EUDAMED is fully functional.

Key information accessible to the public in EUDAMED:

  • Registration of all manufacturers, their authorized representatives and importers placing medical devices on the EU market
  • Registration of devices, the core elements of the UDI database of part B of Annex VI, including the basic UDI and UDI-DI of devices
  • Registration of certificates of conformity, their scope and validity period
  • List of notified bodies designated under the MDR, their identification numbers and their conformity assessment activities through a link to NANDO database and the list of their subsidiaries
  • Scientific opinions of the expert panels and the written justification of the notified body where it has not followed the scientific opinion of the expert panel
  • Clinical investigation reports and their summary
  • The summary of safety and clinical performance reports for implantable devices and class III devices
  • Manufacturer incident reports (partial access) and the field safety notices for Vigilance activities
  • Summary of the results of market surveillance activities on their national territory by each EU Member State.

Key information publicly available outside EUDAMED

  • National measures taken by competent authorities for the placing on the market of single use devices which are reprocessed
  • Types and levels of fees levied by Member States for funding activities carried out by the competent authorities
  • National measures governing the assessment, designation, and notification of notified bodies
  • List of standard fees from notified bodies
  • Summary of each Member State report on its monitoring and on-site assessment activities regarding notified bodies
  • Commission annual summary report of the peer review activities of authorities responsible for notified bodies,
  • Declaration of interests of top-level management of notified bodies
  • Declaration of interests of each member of the MDCG, of its sub-groups except for stakeholder organizations, and of the advisors within the expert panels and expert laboratories
  • Advice provided by the expert panels
  • Names and affiliation of the members of the MDCG.

Important EUDAMED Dates

For the EU Commission this development and implementation of EUDAMED is a high priority. And with help of MDCG, it is going to release different modules as soon as they become functional. Currently the deployment of Actor registration (first module) is planned for December 2020. The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available by May 2021. Afterwards, the remaining modules will be presented as soon as they are operational. Most of the requirements on Transparency and public access to information linked to the EUDAMED, are planned to become fully functional by May 2022. The official web address of the EUDAMED public website will be “ec.europa.eu/tools/eudamed”. It will be available once it is in production and not before.

Turacoz Healthcare Solutions understands medical device regulatory MDR requirements and can assist you in your device approval journey. Our technical writers are experienced industry experts having worked with EMA, FDA and other regulatory agencies in gap analysis, device approval and regulatory queries responses. In addition to the regulatory services, the team also provides publication, medi-marketing and advisory board meetings for medical device companies.

If you have any queries, email us at [email protected].

References

  1. https://ec.europa.eu/health/md_eudamed/overview_en
  2. https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/transparency_factsheet_en.pdf

 

Medical Device Industry and COVID-19: Regulatory Modifications to Consider

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Background

The COVID-19 outbreak is a public health crisis that this generation has never seen before and has presented itself as an unprecedented challenge to the health industry including the Medical Device and Regulatory framework.

There is tremendous burden being faced by first responders and health institutions. Simultaneously, there is increasing pressure on national authorities, EU member states, and economic operators to supply vitally important medical devices at the time of adoption of Regulation (EU) 2017/745.

The unanticipated crisis has had a significant impact on placing devices on the market in the Union while halting the designated work of the notified bodies. The commission recognizes the role of Personal Protective Equipment (PPEs) such as medical gloves, surgical masks, and equipment for intensive care in the current pandemic and has therefore decided to prioritize the demands of such equipment thereby avoiding any potential market disruption.

MDR defers till 2021

Therefore, the European Commission released a proposal earlier in April to defer without any alterations to the guidelines, the enforcement of the EU Medical Devices Regulation (MDR) for a year, applicable from May 26th, 2020. However, the commission made no deferments for the In Vitro Diagnostic Regulation (IVDR), which will be applicable from May 26th, 2022. The aim of the deferment has been to ease the pressure on the medical fraternity to be able to cope and focus with the current crisis and minimize risk to medical professionals.

National Derogation

In scenarios of a public health crisis, such as COVID-19 the Regulation (EU) 2017/745 allows the commission to extend the validity of a national derogation for a limited period of time in exceptional cases for member states in response to address Union-wide shortages of vitally important medical devices in an effective manner.

The Commission has agreed with the European standardization organization to make originally copyright standards (including EN 149 and 14683) freely and fully available by the national standardization bodies. Manufacturers can download a copy for free from the online catalogues of the national standardization bodies.

Furthermore, Directives 90/385/EEC and 93/42/EEC of the regulation empower national authorities on duly justified requests to place medical devices on the market for whom relevant conformity assessment has not been completed but substantial evidence is available to prove interest of public health, patient safety, and health.

Market approval of devices without CE marking

In exceptional circumstances, products can be placed on the market even if no CE marking has been affixed upon them, given that the following conditions are fulfilled:

  • The products manufactured are in accordance with one of the EN standards or other standards referred to in the WHO guidelines
  • The products are part of a purchase organized by the relevant Member State authorities;
  • The products are only made available for the healthcare workers;
  • The products are only made available for the duration of the current health crisis; and
  • The products are not entering the regular distribution channels and made available to other users.

This approval, may bring some relief from the intense pressure on manufacturers to complete the MDD/AIMDD work by giving them an additional year while ensuring devices reach hospitals. Meanwhile, the European parliament and the Council continue to work together to adopt the legislation as mandated implementation date.

Take home message

It is important to note and acknowledge that the framework of manufacturers, regulatory bodies, and agencies continue to work on collaborating and collectively contributing in ensuring that medical devices are used safely amongst patients in this evolving pandemic.

Turacoz Healthcare Solutions understands medical device regulatory requirements and can assist you in your device approval journey. Our technical writers are experienced industry experts having worked with EMA, FDA and other regulatory agencies in gap analysis, device approval and regulatory queries responses. In addition to the regulatory services, the team also provides publication, medi-marketing and advisory board meetings for medical device companies.

If you have any queries, email us at [email protected].