STEP 1: Obtain CE Marking
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.
Class I, non-sterile/measuring/reusable surgical instruments & Class A non-sterile IVDs
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.
Medium-low to High-risk Devices
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.
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.
An overview of Notified Body fees can be found here.
STEP 2: Appoint EU Authorized Representative
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.
STEP 3: Register Your Company and Devices
EUDAMED is the European Database on Medical Devices. It is a publicly available database that contains details about manufacturers, their medical devices, and more.
Per the MDR/IVDR, manufacturers must register themselves and their device(s) in EUDAMED. The company registration request must be approved by both the EU AR and European Competent Authority. However, most device registrations can be completed (“auto-approved”) by the manufacturer.
For more information, including deadlines and how to register, please read: EUDAMED Overview
STEP 4: Identify EU Importer(s)
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 above requirements, manufacturers should understand which entities are taking on this role for their devices.
