[co-author: Alexander Wenzel]

Introduction

The European Commission has published a factsheet addressed to competent authorities of third countries. This factsheet is one of several guidance documents published by the European Commission to clarify points and answer questions regarding the implications of the Medical Device Regulation (MDR) and the In Vitro Medical Device Regulation (IVDR).

The factsheet is intended to facilitate the import into the EU and export of medical devices from the EU during the transition period.

Guidance for third country competent authorities

The factsheet provides general guidance on the MDR and IVDR as well as specific guidance on the reclassification and certification of medical devices during the transition period.

It provides advice for third country authorities regarding the import of medical devices to the EU. The factsheet encourages third country authorities to make manufacturers, trade associations and chambers of commerce aware of the new Regulations.

Similarly, the factsheet encourages third country authorities to inform companies wishing to import medical devices from the EU about the implications for their activities of the new Regulations. The third country authorities can refer to the European Commission website, national EU and EEA authority contact points as well as this factsheet to provide stakeholders with guidance. The factsheet warns of the possibility for market disruptions if stakeholders are not informed in time.

The factsheet also provides guidance concerning the validity of CE Certificates of Conformity issued in relation to medical device certificates issued on the basis of the existing medical device Directives, after the date of the Regulations’ applicability. It provides guidance concerning the coexistence of CE Certificates of Conformity issued in accordance with the Directives and those issued in accordance with the MDR and IVDR.

The Transition period for CE Certificates of Conformity

Medical devices that are the subject of an existing CE Certificates of Conformity issued on the basis of the Directive will have to be re-certified by a Notified Body in accordance with the rules of the MDR and IVDR. Re-certification refers to the fact that a Notified body must issue a new CE Certificate of Conformity for the medical device. Medical devices that are not currently subject to a CE Certificates of Conformity may also require a certificate following entry into application of the Regulations.

Medical devices with CE Certificates of Conformity issued in accordance with the Directives prior to 25 May 2017, can still be placed and made available on the EU market during the 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 transition period is in place to avoid the disruption of the medical device market.

The transition period for certificates of free sales

Certificates of free sales (CFS)[1] can be issued by the competent authorities of the EU Member States on the basis of CE Certificates of Conformity issued on the basis of both the MDR/MDD/AIMD and IVDR/IVDD. Like the CE Certificates of Conformity issued under the Directives and the Regulations CFS issued on both bases will have equal status. CFS based on CE Certificates of Conformity issued by Notified Bodies under the Directives, will remain valid until the corresponding Certificates have expired.

Reclassification of medical devices

The Regulations will implement new risk classification rules for medical devices and in vitro medical devices. This will change the risk classification for a number of medical devices. A medical device could fall within a higher risk class under the Regulations than it currently does.

[1]               CFS are certificates that attest that a device complies with the legislation and may be sold freely in the exporting country.