Special authority release
Continuing to Place Medical Devices in the EU Market: Understanding the MDCG 2022-18 Guidance
General Background
This topic is of the utmost importance to manufacturers of medical devices with an expiring MDD/AIMDD certificate.
The EU Commission has issued the MDCG 2022-18 guidance on how EU Member States´ Competent Authorities could apply Article 97 for non-compliant devices. This guidance explains how to apply for an application of ending non-compliance within a reasonable period of time under Article 97, which allows manufacturers to continue placing their devices in the market, despite the expired certificate, providing a valuable solution for manufacturers, but only if certain conditions are met.
This application has significant impact on both manufacturers and patients and is a valuable opportunity. This procedure ensures that medical devices with acceptable risk levels remain available to patients.
Manufacturers shouldn’t miss out this opportunity to keep their devices on the market and ensure patient access to their medical product.
Below are the requirements for the application outlined in the guidance document MDCG 2022-18, to highlight the specific conditions and steps that must be met under Article 97 for the medical devices. This will help manufacturers navigate the process and increase the likelihood of a successful application.
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
Key points
Key changes that require the manufacturer´s immediate attention:
The key steps involved in PMCF under the EU MDR include:
Who can apply for the application of Article 97?
- Manufacturers of the device with a valid MDD or AIMDD certificate that is or will soon expire, before the EU MDR certificate is issued
Valid – means not suspended or withdrawn certificate.
The key steps involved in PMCF under the EU MDR include:
Which conditions need to be fulfilled?
- The device should not have undergone significant changes in design or intended use according to MDCG 2022-03 since the date of application of EU MDR (26 May 2021).
- The device should not pose an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of public health.
- The device should be in transition to comply with the EU MDR according to Article 120 (3) of the EU MDR.
- The manufacturer should have adapted its Quality Management System to comply with the EU MDR requirements.
- The manufacturer should have already filed an application for conformity assessment with a notified body and have a written agreement with them. (This condition can be waived if the manufacturer can demonstrate reasonable efforts put in finding a notified body).
The key steps involved in PMCF under the EU MDR include:
Who should a manufacturer apply to?
The application should be made to the Competent Authority of the Member State where the Manufacturer or the Authorized Representative of non-EU Manufacturer has its registered place of business.
For instance, if the registered place of business is in Germany, the application should be made to the responsible German Competent Authority.
Which documents need to be provided to CA with the application?
Documents from the Manufacturer:
- EC certificate issued by a notified body in accordance with MDD or AIMDD.
- Declaration of Conformity issued in accordance with MDD or AIMDD.
- Description of the date from which the device is not or will not be compliant with the EU MDR and the reason for it, as well as an estimated time for completion of conformity assessment and issuance of EU MDR certificate by the notified body.
- A report containing a summary of relevant PMS data, specifically incidents, serious incidents, and field safety corrective actions.
- Recent audit report by the notified body with findings and their resolution.
- EU MDR Quality Management System certificate or confirmation by the manufacturer with supporting documents, including a valid ISO 13485 certificate.
Documents to be written by the notified body and provided by the manufacturer:
- Confirmation letter by the notified body that the application for EU MDR certification has been accepted and a contract with the manufacturer has been signed.
- Commitment by the notified body to inform the Competent Authority about any major safety-related shortcomings identified during conformity assessment.
What is issued at the end of evaluation by CA?
Letter of Acceptance of Manufacturer’s Commitment and Plan of Action to correct the non-compliance
How long will a CA allow non-compliant medical devices to be sold on the market when conditions for Article 97 are met?
This is decided on a case-by-case basis. The maximum allowed period is typically 12 months, but it can be extended if there are valid reasons for doing so.
The key steps involved in PMCF under the EU MDR include:
What are the next steps after fulfilling the requirements of Article 97 of non-compliant devices and MDCG 2022-18 guidance document?
- Notify distributors and importers (if applicable) about the non-compliance and the steps being taken to end it.
- Keep the Competent Authority (CA) informed about any safety concerns, changes to the application, or changes to the EU MDR certification dates.
Our Services
AKRA Team offers a range of services to help manufacturers navigate the application process under Article 97 for their devices.
Whether help preparing a successful application is needed, a professional review of an application a manufacturer has already created is needed, or a manufacturer wants to consult with experts on this topic, AKRA TEAM is here to assist. We can help manufacturers prepare an application that meets all the requirements and increase the likelihood of a successful outcome.
Training
AKRA TEAM provides training for global regulatory requirements (e.g., US FDA, Health Canada, PMDA, NMPA, TGA, Singapore, Malaysia, UKCA, Switzerland, etc.). Our team of senior consultants have previous experience working in global markets and can provide training suited to the relevant regulatory jurisdiction.
Process and Templates Development
AKRA TEAM has proven procedure and document templates are available for global regulatory needs.
Gap Assessment
AKRA TEAM offers comprehensive gap assessments to highlight areas of risk or improvement prior to submission. AKRA TEAM will rank risks from high to low while offering mitigations to close any identified gaps.
AKRA Team offers a range of services to help manufacturers navigate the application process under Article 97 for their devices.
Whether help preparing a successful application is needed, a professional review of an application a manufacturer has already created is needed, or a manufacturer wants to consult with experts on this topic, AKRA TEAM is here to assist. We can help manufacturers prepare an application that meets all the requirements and increase the likelihood of a successful outcome.
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