Industries
Medical Devices
In the European Union, medical devices play a pivotal role in enhancing the well-being of individuals and stand as one of the largest global markets. The regulation of medical devices within the EU is overseen by EU Regulation 2017/745. Engaging the services of a European Authorized Representative (EC REP) for EEA member states is a mandatory step in compliance with the European Medical Device Regulations, particularly MDR (EU) 2017/745. This ensures alignment with key aspects of the CE marking criteria.
Article 11 - Authorised Representative
- Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.
- The designation shall constitute the authorised representative’s mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.
- The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request. The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers.
Why choose MedNet as your EC-REP?
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Target Markets You Can Enter with MedNet EC-REP
In Europe, medical device regulations are divided into three key regions, each influencing the rules and processes for your specific market. Explore how we guide you through your market's regulatory landscape and let MedNet streamline your market entry.
- European Union
- Medical Devices in the European Union and Northern Ireland are regulated by the Medical Device Regulation (EU) 2017/745 (MDR). This regulation requires non-EU manufacturers to appoint an European Authorized Representative (EC-REP) to place Medical Devices on the market in EU member states or Northern Ireland. MedNet EC-REP Office in Germany is your primary contact point with local authorities and ensures the registration of your products in the respective member state database.
- Great Britain
- With Brexit, the British market (England, Scotland and Wales) operates independently of the EU and follows local legislation. The UK MDR 2002 requires non-British manufacturers to appoint a UK Responsible Person (UK RP) to place Medical Devices on the British market. Situated in Great Britain, MedNet as your UK Responsible Person is aware of the local regulations and current transitional rules in the United Kingdom. We register your products on the British Medicines and Healthcare Regulatory Agency (MHRA) database quick and reliable.
- Switzerland
- Hence Switzerland is not part of the EU and the former Mutual Recognition Agreement (MRA) between the EU and Switzerland has expired, Medical Devices are handled under local Swiss regulations. The MedDO determines non-Swiss manufacturers to appoint a Swiss Authorized Representative (CH-REP) to access into Switzerland and register your Medical Devices with the local authority Swissmedic. MedNet as your CH-REP leads you through the Swiss regulatory landscape.
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