The European Commission (EC), the EU body focused on the improvement and development of medical devices regulation, issued guidelines describing the way the EU-wide derogations for medical devices should be applied under the Medical Devices Regulation 2017/745 (MDR).
The MDR intends to implement an entirely new regulatory framework for medical devices. The new regulation will replace the Directives – Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). It will establish the highest standards of public health protection by ensuring that any and all medical devices allowed to be marketed in the EU meet the appropriate safety, quality, and performance requirements.
At the same time, the MDR implements additional obligations and requirements medical device manufacturers shall meet in order to be eligible to market their devices in the EU. In particular, the new regulation requires that all medical devices initially approved under the Directives, should be subject to re-certification since the requirements medical devices shall meet under the MDR are partially different from ones set forth by the Directives. Such additional requirements are intended to improve the overall quality and safety of medical devices marketed in the EU, but at the same time, they could cause certain delays in regulatory processes and procedures and thus impact the availability of medical devices on the market.
The European Commission also intends to implement solutions preventing potential shortages that could take place due to the restrictive and quarantine measures introduced in the EU Member States and other countries in order to address the pandemic.
EU-wide Derogations and Special Frameworks
It is important to mention that MDD, AIMDD, and MDR contain special provisions allowing national regulating authorities to grant permission on marketing medical devices before the appropriate conformity assessment has been duly carried out in case if it is reasonably necessary to protect public health. This framework is known as the “national derogation.”
The MDR expands the scope of application for the derogations for medical devices. Under the MDR, the EC is also entitled to extend the national derogation to the EU territory, which refers to the “Union-wide derogation”. Such an extension should be applied only in exceptional cases and also should be limited in time. The EC is allowed to use the Union-wide derogations in case if it is the only available way to prevent shortages of vitally important medical devices.
The present EC guidelines describe the particular way the Union-wide derogations framework should be applied and provides details about the criteria to be considered by the EC when making a decision on the eligibility of the medical device in question for the Union-wide derogation.
The new Regulation on medical devices sets forth special rules and procedures regulating the way the derogations should be applied on each level. In particular, the MDR provides the following:
- Article 59 entitles the national regulating authorities with the right to grant national derogations for medical devices that would be valid within the territory of the appropriate Member State.
- Article 59(2) requires the national regulating authorities to inform the EC and regulating authorities of other Member States about any and all national derogations granted. According to the Regulation, this could be performed through the special central repository managed by the EC.
- The information about national derogations granted in the Member States could be considered by the EC for granting the Union-wide derogation.
- Article 59(3) allows the EC to extend the validity of the national derogation to the territory of the European Union, in case if such extension is reasonably necessary to ensure public health protection. At the same time, it is important to mention that the EC could grant Union-wide derogations only on the basis of the appropriate national derogations granted by the national regulating authorities of the EU Member States.
According to the EC guidelines, the EC starts the process with the consulting with all Member States. This should be performed by the Medical Device Coordination Group (MDCG). As a result of such consultations, the EC will determine the eligibility of the national derogation in question for the application of the Union-wide derogation framework. In case if the national derogation for the medical device has been determined as relevant, the EC commences the procedure itself.
As it is stated in the EC guidelines when making a decision regarding the application of the Union-wide derogation on the basis of the appropriate national derogation, the EC considers the following requirements and criteria:
- Procedural requirements:
- A union-wide derogation should be based on the national derogation granted for the same medical device in at least one of the EU Member States.
- The national derogation should be accompanied with the appropriate justification.
- Detailed information about the national derogation for the medical device should be available to the EC. The scope of the information includes the validity period and also the reports generated in the course of post-market surveillance.
- The national derogations shall explicitly indicate the particular medical device it is granted to, including the details about the medical device manufacturer and indications for use.
- The national regulating authority that granted the initial national derogation shall duly provide and make available the information submitted by the medical device manufacturer, and also the information about the assessment carried out by the national regulating authority.
- The information provided shall demonstrate that the medical device manufacturer has duly performed all reasonable steps necessary to perform the conformity assessment, while such assessment has not been properly performed due to the impact of the factors beyond the manufacturer`s control.
- The medical device in question is deemed vitally important.
- The appropriate substituting devices already placed on the market are absent or insufficient.
- There is no information indicating that the medical device in question will expose patients to additional risks.
- The national derogation has the appropriate validity period based on the needs related to the device.
- It is reasonably necessary and relevant to extend the validity of the national derogation in question to the whole territory of the European Union.
The information covered by the scope of the aforementioned points is reasonably necessary for the EC to evaluate whether the justification for the Union-wide derogation is sufficient.
Summarizing the information described hereabove, when considering the possibility to apply the Union-wide derogation, the EC makes its decision based on the following points:
- The understanding of the reasons and factors preventing medical device manufacturer from performing the conformity assessment as required in accordance with the general rules,
- The understanding of the reasons the medical device in question is vitally important and should be placed on the market, and
- The information regarding the particular way the medical device manufacturer intends to maintain compliance or initiate the withdrawal upon the expiration of the initial derogation term.
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