[co-author: Alexander Wenzel]

Introduction

The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities responsible for the procurement of (in vitro) medical devices with guidance concerning Medical Device Regulation (MDR) and the In Vitro Device Regulation (IVDR).

This factsheet is one of several guidance documents published by the European Commission to clarify points and answer questions regarding the implications of the MDR and the In Vitro Device Regulation.

Although the main aim of the factsheet is to help economic operators prepare for public tenders involving (in vitro) medical devices, it can also be useful to companies wishing to participate in a medical device tender.

The procurement ecosystem

Coexistance of CE Certificates of Conformity

The factsheet provides general guidance concerning the MDR and IVDR as well as specific guidance concerning the reclassification and certification of medical devices during the transition period. More information on this is available in our blog post here.

The factsheet elaborates in particular on the practical aspects of the transition period. Medical device with CE Certificates of Conformity issued in accordance with the Directives and medical devices with CE Certificates of Conformity issued in accordance with the MDR/IVDR will coexist on the market during this period.

Equal status of CE Certificates of Conformity

Coexistance means, that these medical devices will have an equal status on the EU market and thus in public tenders. An entity organising a public tender cannot favour one medical device over the other because of a CE Certificate of Conformity issued in accordance with the older Medical Device Directive or In Vitro Medical Device Directive.

Transition period

The transition period will be until 27 May 2024 for the MDR and until 27 May 2025 for the IVDR. The Factsheet explains that this period is necessary considering the more stringent criteria that manufacturers are required to meet, in particular concerning clinical evaluation. In addition, Notified Bodies need to be designated anew to the Regulations.

Notified bodies

Notified Bodies are currently designated in accordance with the rules provided by the MDD/IVDD. They will now need to be designated in accordance with the rules of the MDR and IVDR. As the factsheet explains, Notified Bodies will be subject to stricter rules for designation, additional requirements and will have additional responsibilities.

The designation of Notified Bodies within the Regulations involves assessors from different national and European authorities. It can take up to twelve months or more. This may result in a bottle neck effect and delays for issuing the new CE Certificates of Conformity, if many companies apply for support to the few designated Notified Bodies at the same.

The factsheet warns that there will be limited time available for companies to get all their medical devices certified before the dates of application of the Regulations. It explains that it is unlikely that all medical devices will be certified by the Dates of Applications because of the transition for the Notified Bodies.

This is why CE Certificates of Conformity issued in accordance with the rules of the MDD/IVDD will remain valid until a certain date. Depending on the exact date of issuance of the medical device’s CE Certificate of Conformity, these CE Certificates will be valid for a certain amount of time after the applicability of the MDR/IVDR. Please contact our team for more concrete advice on the date of applicability for your device.

Medical Devices that have reached the final user

The factsheet also points to the fact that a user of a medical device with a CE Certificate of Conformity issued in accordance with the MDD/IVDD will be able to continue using the medical device. This possibility is, however, conditional on confirmation that they are the final user and that the medical device has reached the final user before 26 May 2025. Manufacturers will be obliged to remove any medical devices with CE Certificates of Conformity issued in accordance with the MDD/IVDD from the supply chain if these do have not reached their final user by 27 May 2025.

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