The European Union Medical Device Regulation (EU MDR No. 2017/745) and In Vitro Diagnostic Regulation (EU IVDR No. 2017/746) introduced significant changes to EU medical device regulations, replacing Medical Device Directive (MDD), Active Implantable Medical Device Directive (AIMDD) and In Vitro Diagnostic Medical Device Directive (IVDMDD). The new regulations came into force on May 26th, 2021 for MDR and May 26th, 2022 for IVDR for all EU member countries. Compliance with this regulations is mandatory for medical device companies (legal manufacturers) that want to market their products in the EEA (European Economic Area). The EU MDR regulations were designed to improve the safety and performance of medical devices distributed within EU.

EU MDR (2017/745) and EU IVDR (2017/746), impose the requirement of having an EU Authorized Representative for all the medical devices and in vitro diagnostics of manufacturer established outside the European Union (third countries). This requirement applies to all medical devices, regardless of the device class. Thus now, any foreign manufacturer located outside EU, that wishes to introduce medical devices on European market, requires an Authorized Representative (also known as EC REP or EU-AR) established within one of the Member States. The EC REP/EU-AR acting on behalf of manufacturer takes the responsibility for medical devices placed on the EU market and co-operates directly with the authorities of the Member States. To ensure efficient and fluent market introduction and post-market surveillance of the device, both the Manufacturer and the Authorized Representative should continuously possess at their disposal at least one Person Responsible for Regulatory Compliance (PRRC), who has the requisite expertise in the field of medical devices. The obligation of permanent access to PRRC and required qualifications for this role are defined in article 15 of MDR.

If you are looking for a representative with an experience in regulatory affairs, Health-Med will be glad to support you. We assist our Clients in understanding MDR obligations and provide technical support as well as practical knowledge.

Health-Med is also prepared for the role of importer under MDR, which not only takes responsibility for device compliance with current European legislation, but also makes some extra checks to the supply chain and, most importantly, is accountable for placing the device on European market for the first time. If you wish to learn more about the responsibilities of EU Importer, you might be willing to check a Blue Guide and EMA factsheet for Economic Operators of MDR and IVDR.

Under EU MDR all the medical devices have to be assigned with an unique device identification code (UDI). For medical devices of class III and IIb, UDI device identifier should be assigned before applying to the notified body for conformity assessment, and then referenced in the issued certificate and registered on the European Database for Medical Devices (EUDAMED). At Health-Med, we offer comprehensive services and support in field of medical devices covering also EUDAMED Registrations, Vigilance and CAPA.

If you have any questions regarding placement of medical devices on the market, don’t hesitate to contact us. Our experienced team will provide detailed information about our services and prepare a solution tailored for you.

Please, contact us for detailed information.