No Leaning back for MDD Medical Devices
By: Amy Eikelenboom – Co-founder of NAALA
Published on 15 October, 2021
Do you manufacture medical devices certified under the Medical Devices Directive (hereinafter: “MDD”)? You may know that with the applicability of the Medical Devices Regulation (hereinafter: “MDR”) there is no leaning back for MDD Medical Devices.
Many manufacturers are aware they have a longer period before they need to fully comply with the MDR. Nonetheless, manufacturers of MDD CE certified medical devices are not completely off the hook. We have noticed that not every manufacturer is aware of this. In this blog we summarize the requirements applicable to all medical device manufacturers.
What is the soft transition period?
The MDD has been replaced by the MDR on May 26th, 2021. In order to allow all medical devices to meet necessary quality, safety and performance requirements, the MDR allows for a smooth transition from the MDD to the MDR. Medical devices certified under the MDD may have (up to) an additional four years to be placed on the market. This does not apply to medical devices that are classified as a class I medical device under the MDD and remain a class I medical device under the MDR. These medical devices should already comply with MDR requirements.
It is important to note that this transition period applies as long as the medical device continues to comply with the MDD and there are no significant changes in its design and intended purpose.
Despite this soft transition period, the following MDR requirements became applicable to all medical devices:
- Post-market surveillance,
- Market surveillance,
- Vigilance, and
- Registration of economic operators and of devices.
Infographic Soft Transition Period
Post-market surveillance (hereinafter: “PMS”) is defined as all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market, or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.
Every manufacturer of medical devices should have a PMS system available to actively and systematically gather, record and analyze relevant data on the quality, performance and safety of the medical device throughout the entire lifetime. The data gathered shall be used to:
- Determine corrective and preventive actions,
- Update the benefit-risk determination and to improve risk management,
- Update the design and manufacturing information, instructions for use and labelling,
- Update clinical evaluations,
- Update the summary of safety and clinical performance,
- Identify needs for preventive, corrective or field safety corrective action,
- Identify options to improve the usability, performance and safety of the device,
- When relevant, contribute to the PMS of other devices, and
- Detect and report trends.
The PMS activities should be based on a PMS plan, part of the technical documentation of the medical device.
For class I medical devices, the results and conclusions following from the PMS data gathered shall be reported in a PMS report. For class IIa and higher classified medical devices this information needs to be summarized in a periodic safety update report (“PSUR”).
Vigilance concerns the reporting of incidents to the relevant competent authorities. For manufacturers of medical devices, there are certain situations that must be reported to the authorities. Specifically, the following must be reported for all medical devices placed on the European market:
- Any serious incident with devices on the European market, except for side-effects which were yet expected, clearly documented in the product information, quantified in the technical documentation, and are subject to trend reporting.
- Any field safety corrective action in respect of devices on the European market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the European market, if the reason for the field safety corrective action is not limited to the device made available in the third country.
Market Surveillance refers to the checks performed by competent authorities on the conformity characteristics and performance of devices. This may include the review of documentation and physical or laboratory checks on the basis of adequate samples.
All manufacturers of medical devices are subject to the annual surveillance activity plans of competent authorities. What may they check? Specific attention has been communicated on activities related to risk assessment and risk management, vigilance data and complaints. Competent authorities may ask to make documentation and information available and/or perform unannounced inspections of the premises.
The European Commission has made available certain modules of the European database on Medical Devices; Eudamed. The final version of Eudamed shall include the following electronic systems:
- Economic operators,
- Notified bodies and certificates,
- Clinical investigations,
- Vigilance and post-market surveillance, and
- Market surveillance.
This system requires manufacturers to, amongst other things, register themselves and their medical device(s). At the moment the following Eudamed modules are available:
This means that all manufacturers of medical devices must submit the required information in the Eudamed database.
Are you curious about what NAALA can do for you? Or would you like to know more about this topic? Feel free to contact us!
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only. Changes in legal or regulatory requirements may occur at short notice, which we cannot reflect on a daily basis.
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