The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
The document outlines the main priorities to be considered by the parties involved and is also intended to be used as a roadmap in the course of the actual implementation. The MDCG reserves the right to amend implementation timelines if deemed reasonably necessary.
EU Reference Laboratories
Under the new regulatory framework, a new type of independent scientific body will be introduced – the EU reference laboratories. Their main purpose will be to perform additional testing of high-risk (Class D) medical devices to assess their actual effectiveness and their compliance with the applicable regulatory requirements such devices should meet to be approved for marketing and use in the EU. Additionally, the EU reference laboratories duly designated in the sphere of IVDDs will be responsible for testing some CE-marked devices before they become available to healthcare professionals and patients. Apart from this, these entities will also perform advisory functions in the appropriate sphere. Thus, the activity of EU reference laboratories will be focused on ensuring the safety and performance of Class D IVDDs marketed in the EU.
According to the new regulation, the EU reference laboratories could be designated in the sphere of in vitro diagnostic medical devices starting from November 2020. At the same time, the MDCG mentions that such designation is not mandatory. If there are no EU reference laboratories designated as described above after the new regulatory framework becomes effective, this will not impact the general regulatory procedures or availability of medical devices on the market. The regulatory provisions addressed herein will not be applied.
At the same time, the current transitional framework prescribes a totally different approach: under the transitional rules, participation of a duly designated EU reference laboratory is mandatory in order for Class D in vitro diagnostic medical device to be allowed for marketing and use in the EU. The particular regulatory requirements for the operating activity of the EU reference laboratories, as well as the fees associated thereto, are still under development and are expected to be released by the European Commission shortly, together with the commencement of the designation process by announcing a call for designation by virtue of which the EC will invite the interested entities to apply for a designation as described above.
According to the document published by the MDCG, the priority actions to be taken in this regard include:
- Discussion with Member States on practical aspects related to EU reference laboratories;
- Adopt implementing acts on tasks and criteria and on fees to be levied by the EU reference laboratories;
- Carry out survey on needed capacity of EU reference laboratories;
- Issue call for application to Member States and the Joint Research Centre;
- Assess the applications and designate the EU reference laboratories;
- Investigate a Union contribution for tasks that are not covered by fees.
Another important matter addressed in the guidance relates to the common specifications – legally binding requirements on certain elements of conformity assessment, adopted in the form of an implementing act. The MDCG states that the medical device manufacturer will have to justify all deviations from the common specifications and demonstrate that the device still meets general requirements in terms of safety and performance in order to be allowed to place it on the market. According to the document, the adoption of common specifications is not mandatory. However, they are expected to make the regulatory framework more transparent and predictable for all the parties involved. The medical device manufacturers will also be allowed to refer to the common specifications in order to demonstrate compliance with the regulatory requirements set forth by the IVDR. Additionally, conformity assessment bodies (EU notified bodies and EU reference laboratories) will also perform an assessment with regard to compliance with the common specifications.
The MDCG also mentions that common (technical) specifications were initially implemented under the previous regulatory framework based on the Directive 98/79/EC, while the new ones related to high-risk in vitro diagnostic medical devices are currently under development. According to the guidance, the aforementioned common (technical) specifications will be used as a basis for new common specifications without being subject to significant changes, while the newly developed specifications will be aligned with the existing ones.
The priority actions to be taken in this regard include:
- Propose the sets of CS will form part of the first adoption round;
- Agree on the text to be adopted as part of the first round;
- Adopt the first implementing act containing common specifications.
Guidance for Notified Bodies
Due to the important role to be played by the notified bodies under the new regulatory framework, the MDCG pays special attention to guidance for notified bodies dedicated to various matters related to the new regulations. It is stated that the first guidance dedicated to the classification of in vitro diagnostic medical devices has already been published, and more guidance documents are expected to be released in a while. In particular, the new guidance documents will address the aspects related to notified body designation codes associated with the scope of their designation in terms of types of medical devices they will be allowed to assess, and also on the cooperation between the medical device manufacturer, the notified body and the EU reference laboratories as new participants of the regulatory procedures.
The MDCG outlines the following priority actions:
- Complete and endorse guidance on notified body designation codes;
- Complete and endorse guidance on batch testing for notified bodies.
Performance Evaluation and Expert Panels
The new regulation will also introduce more detailed requirements on the performance evaluation of in vitro diagnostic medical devices. In particular, performance evaluation will be based on three core elements:
- Scientific validity;
- Analytical performance; and
- Clinical performance.
The IVDR will also describe in detail the way compliance with these requirements should be assessed. The scope of documents to be provided by the responsible party will include a performance evaluation plan, a performance evaluation report, and a post-market performance follow-up plan.
As mentioned, the actual performance of high-risk (Class D) in vitro diagnostic medical devices will be subject to an assessment carried out by the EU reference laboratories duly designated to conduct such activities. In the case of novel medical devices, additional consultation with the expert panels could be required.
In general, the priority actions to be taken in this regard include:
- Complete and endorse guidance on performance evaluation;
- Develop and endorse a clarification on what constitutes a “type of device” and on the process to be followed by notified bodies in context of views of the expert panel;
- Develop and endorse template for summary of safety and performance.
In summary, the present document describes the most important steps to be taken in the course of implementation of the new regulatory framework for in vitro diagnostic medical devices to be introduced under the IVDR. The document outlines the current issues and highlights the aspects requiring the most attention to be paid.
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