How to sell your medical devices and IVDs in Europe

In 2017, two new European regulations were published: the MDR and IVDR. These replace the previous legislation, also known as the ‘Directives’ – the Medical Devices Directive (MDD) 93/42/EEC, Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC and the In Vitro Diagnostic Directive 98/79/EC (IVDD).

The below outlines the basic steps to comply with MDR and IVDR.

NOTE: there is a transition period for ‘legacy’ devices. These are products that may still be legally placed onto the market under the Directives, even after the MDR and IVDR dates of application. For more information, please read: What are Legacy Devices?

Manufacturers must obtain CE marking for all medical devices and IVDs before the products can be sold in the EU. This process includes generating a technical documentation file (TDF) and quality management system (QMS) based on the requirements of the MDR/IVDR. The TDF and QMS may further require review by a Notified Body. Notified Bodies are organizations accredited and supervised by the European national Competent Authorities. Their role is to evaluate if products have met the minimum safety and efficacy requirements. If the Notified Body deems the minimum requirements have been met, they will issue a CE marking certificate. 

For the lowest risk devices, manufacturers will self-certify. This means that the manufacturer will develop a compliant technical file and implement a quality system. Then, they will self-assert that the device has met the minimum requirements of the MDR/IVDR. The manufacturer will self-affix the CE marking symbol to the device and sign their Declaration of Conformity. A Notified Body is not involved in any part of this CE marking process.

For all higher risk products, manufacturers must submit their technical documentation file (TDF) to a Notified Body for review. The Notified Body certification process generally consists of a desktop audit of the TDF and onsite audits of the manufacturer’s quality system. However, as a byproduct of the COVID-19 pandemic, many audits are now hybrid: a combination of virtual and onsite.

The Notified Body review process can take 12 months or more. The timeline depends on the backlog of applications with the Notified Body, the number of products, the device classification, and volume and severity of non-conformances found during the audits. Upon successful completion, the Notified Body will issue a CE certificate, and the manufacturer may begin placing devices onto the European market.

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Manufacturers outside of the European Single Market must appoint an EU Authorised Representative (AR). Under the MDR and IVDR, the EU AR shares liability with the manufacturer for the product on the market and therefore plays a critical role.

The EU AR must appear on the device label and Declaration of Conformity. Further, they are the point of contact between you and the European national Competent Authorities.

An EU Authorized Representative is required in order to CE mark a device. The Notified Body will request proof that the EU AR has been appointed during its audit and where one has not been, the manufacturer will be issued a non-conformance. 

EUDAMED is the European Database on Medical Devices. It is a publicly available database that contains details about manufacturers, their medical devices, clinical investigations, incident reporting, and more.

Per the MDR/IVDR, manufacturers must register themselves and their device(s) in EUDAMED. The manufacturer’s registration request must be approved by both the EU AR and competent authority. However, the device registrations can be completed directly by the manufacturer.

EUDAMED was originally supposed to be fully functional by May 2020. However, EUDAMED has been postponed. For the most current understanding of EUDAMED’s deadlines, please read: EU Commission Proposes EUDAMED Gradual Rollout

The EUDAMED delay means that, while it is the required system under the MDR and IVDR, it is not yet mandatory.

Until EUDAMED is fully functional, the requirements of the old Directives, which involves notifying individual European competent authorities on a case-by-case basis, are applicable. 

An importer is the person (natural or legal) that first places a device from a third country onto the Union market.

The importer is subject to certain requirements under the MDR/IVDR. For example, the importer must identify themselves on the device label, packaging or in a document accompanying the device. And among other things, they are required to ensure proper traceability of the devices, ensure the devices are appropriately CE Marked, and report the manufacturer if they have “any reason to believe that the device presents a serious risk or is a falsified device”.

While it is ultimately the importer’s obligation to meet the requirements, at the very least from a device traceability standpoint, manufacturers should understand which entities are taking on this role for their devices.