The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has published a guidance document dedicated to the application of transitional provisions for certification of class D in vitro diagnostic medical devices according to the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).
It is important to mention that the position described in the document does not constitute an official position of the European Commission as the regulating authority in the sphere of medical devices. The purpose of the document is to provide additional clarifications on the matter to be considered by the medical device manufacturers and other parties involved in order to achieve and sustain compliance with the applicable regulatory requirements set forth under the current European legislation. Hence, the provisions of the guidance do not create any obligations, and in case of any discrepancies with the provisions of the respective EU regulations, the latter shall prevail.
The document describes the approach to be applied in the case of in vitro diagnostic medical devices assigned to the highest class under the risk-based classification – Class D. Due to the increased risks associated with the use of such devices, an additional examination is required in the course of the certification process. In particular, the present MDCG guidance states the following:
- Class D devices should be subject to additional examination by expert panels and/or EU reference laboratories;
- Since the appropriate EU reference laboratories are still to be designated, an alternative approach should be applied;
- During the transitional period, the notified bodies conducting the conformity assessment of Class D in vitro diagnostic medical devices are entitled to issue certificates without the involvement of the EU reference laboratories due to their absence;
- Such a certificate issued by the notified body remains valid until its expiration irrespectively of the designation of the appropriate EU reference laboratory;
- Once the EU reference laboratory has been designated, the general procedure should be followed, including in terms of re-certification.
The regulatory matters addressed in the document are based on the Medical Devices Regulation 2017/746, which is intended to supersede the appropriate Directive. As prescribed by the IVDR, an entity (a medical device manufacturer) interested in placing the product classified as a Class D medical device shall apply for a conformity assessment. The appropriate application should be submitted to the Notified Body, provided that the scope of designation of the latter covers the necessary type of medical devices. According to the present MDCG guidance, in addition to the assessment by the notified body, under certain conditions particular elements may be reviewed by an expert panel and/or tested by an EU reference laboratory (EURL). However, it is stated that the aforementioned EU reference laboratory framework is still to be established – the regulating authority is currently working on the development of the appropriate regulations.
The present MDCG guidance is intended to provide the medical device manufacturers, as well as the other parties involved, with additional clarifications and recommendations on the particular way the provisions of the new Regulation should be applied during the transitional period. In particular, the document describes the aspects associated with expert panels and EU reference laboratories.
Transitional Regime in Detail
In order to assist medical device manufacturers intending to place their Class D IVDs on the market before the IVDR takes effect, the MDCG describes in detail the most important aspects of the application of the new regulatory requirements, namely:
1. Class D IVD application admissibility. According to the document, the notified bodies should accept the applications submitted by the medical device manufacturers with regard to Class D IVDs. At the same time, they are not allowed to issue the certificates unless the expert panels will be fully operational, and the respective expert panel will provide its opinion (if necessary).
2. Performance evaluation report. In accordance with the Regulation, “the notified body shall provide the performance evaluation report of the manufacturer to the expert panel within five days of receiving it from the manufacturer”. In the case of a newly established expert panel, the calculation of the period should start from the date the panel commences its activity.
3. An additional consultation of an expert panel is required in the case of a novel medical device, providing there was no previous certification for medical devices of the same type. The notified body is responsible for determining the necessity of such a consultation.
4. The expert panel shall provide its response to the notified body within 60 days from the date the request has been received. It is important to mention that the same timeline will be later applied for the EU reference laboratories.
5. Due to the absence of the designated EU reference laboratories, the notified bodies are allowed to accept the applications for certification of Class D in vitro diagnostic medical devices and issue the appropriate certificates. This would be allowed during the whole transitional period, provided there is no EU reference laboratory designated for the particular group or category of medical devices subject to review.
6. Moreover, the certificate issued as described above (solely by the notified body without the engagement of the EU reference laboratory) will remain valid for its whole initial validity period, even if the appropriate EU reference laboratory will be designated. At the same time, once the appropriate EURL has been designated, the medical device manufacturer shall comply with any and all applicable regulatory requirements for communications with the EURL – for instance, in terms of re-certification. In particular, the EU reference laboratory with the appropriate scope of designation should be involved in case of re-certification.
In summary, the present MDCG guidance describes the approach to be applied during the transitional period in order to comply with the provision of the In Vitro Diagnostic Medical Devices Regulation 2017/746 in terms of conformity assessment. In particular, the document addresses the situations when the EU reference laboratory entitled to conduct additional assessment prescribed under the applicable regulatory requirements still has not been designated. The approach described in the MDCG guidance is intended to facilitate the placement of the high-risk Class D in vitro diagnostic medical devices on the market and ensure their uninterrupted availability during the transitional period before the EU reference laboratories will be duly designated and fully operational. The document outlines the most important aspects associated thereto, including the ones related to the validity of the certificates issued by the notified bodies under the transitional regime framework, as well as the general response timelines to be applied in terms of review.
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