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 overview below details the basic steps to comply with MDR and IVDR. Note, there is a transition period for ‘legacy’ devices, which 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?
1) Obtain EU 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.
For the lowest risk devices – Class I, self-certified medical devices and Class A, non-sterile IVDs – manufacturers will self-certify. This means that the manufacturer will develop a TDF and QMS and then self-assert that the device has met the minimum requirements of the MDR/IVDR. The manufacturer will self-affix the CE mark to the device; a Notified Body is not involved in any part of this CE marking process.
For all higher risk products, manufacturers must submit their completed TDF to a Notified Body for assessment. The Notified Body review generally consists of a desktop audit of the TDF and onsite audits of the manufacturer’s QMS. However, due to the COVID-19 pandemic, many audits are now conducted virtually.
The overall 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 and classifications included, and number and severity of non-conformances found during the review. Upon successful completion, the Notified Body will issue a CE certificate, and the manufacturer may begin placing devices onto the European market.
Additional information related to the MDR TDF and IVDR TDF documentation requirements can be found on our other service pages, along with information about how Casus can provide support in drafting these files.
2) Appoint EU Authorized Representative (EC-REP)
Manufacturers not located in 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 responsible as a local contact for the EU national Competent Authorities.
An EU Authorized Representative is required in order to CE mark a device. The Notified Body will require proof that the EU AR has been appointed during its assessment and where one has not, the manufacturer will be issued a non-conformance.
For more information, please read: European Authorized Representative
3) Register Company and Devices
The MDR and IVDR designate EUDAMED (European Database on Medical Devices) as the mandatory registration system. Manufacturers must register themselves as Actors and register their device(s) in EUDAMED. The manufacturer’s Actor 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, the EU Commission has postponed EUDAMED. For the most current dates, please read: New Mid-2025 Implementation Date?
This delay means that, while EUDAMED is the required system for both the MDR and IVDR, it is not yet mandatory.
Until EUDAMED is fully functional, the requirements of the old Directives, which involves notifying individual national competent authorities of new devices on the market, are applicable.
4) Identify EU Importer
Manufacturers should identify the entity(ies) that will be acting as their EU importer. The importer is the entity that first places the product on the market from outside the EU. The importer must identify themselves on the device label, packaging or in a document accompanying the device. Further, the importer has some compliance verification responsibilities they must complete before placing a product on the market. These responsibilities are noted in Article 13 of both the MDR and IVDR.
For additional information, please read: MDCG Guidance related to Importers and Distributors