Industries
Authorised Representative for Medical Devices
Non-EU manufacturers of medical devices are required to appoint a local representative in the regions where they intend to distribute their products. This appointment ensures compliance with the local regulations governing the safety and performance of medical devices. In the European Union (EU), the United Kingdom (UK), and Switzerland, medical devices are subject to specific regulations that are essential for gaining market access and ensuring the safety of patients. At MedNet, we offer professional services as an EC Representative (EC-REP) for the EU, CH-REP for Switzerland, and UK Responsible Person (UK RP), assisting non-EU manufacturers with regulatory requirements in these key markets.
EU Regulatory Requirements for Medical Devices
In the European Union, medical devices are regulated under the Medical Device Regulation (MDR) 2017/745 . This regulation has significantly changed the landscape for medical device manufacturers, particularly those based outside the EU.
Non-EU manufacturers must designate an Authorized Representative within the European Union. This representative acts as a liaison between the manufacturer and the EU authorities, ensuring that the manufacturer meets all regulatory obligations.
Key responsibilities of an EC-REP include:
- Maintaining and providing access to the technical documentation for the device.
- Ensuring that the manufacturer complies with post-market surveillance and reporting requirements.
- Acting as a contact point for the national competent authorities and notifying them in case of incidents or safety issues.
- Representing the manufacturer in dealings with EU regulatory bodies.
MedNet offers comprehensive services to assist non-EU manufacturers in fulfilling their regulatory obligations under the MDR. Our team is well-versed in European regulations and provides reliable guidance to ensure that your devices are compliant.
More Information: EC-REP for Medical Devices
Watch the Video: Appointing an Authorized Representative (EC-REP) for Medical Devices and IVD`s
Discover how MedNet EC-REP GmbH simplifies EU compliance for medical device and IVD manufacturers with authorized representative and seamless registration services.
Navigating Medical Device Regulations in the UK
Following Brexit, the UK has established its own regulatory framework for medical devices. The Medicines and Healthcare products Regulatory Agency (MHRA) now oversees medical device regulation in the UK.
Non-UK manufacturers must appoint a UK Responsible Person (UK RP) to ensure that their devices comply with UK regulations. Similar to the role of the EC-REP in the EU, the UK RP acts as the point of contact between the manufacturer and the MHRA.
Key responsibilities of the UK RP include:
- Ensuring that the device complies with UK regulations and is properly CE-marked (or UKCA-marked, as applicable).
- Keeping records of the device’s technical documentation.
- Submitting relevant documentation and data to the MHRA.
- Acting as the point of contact for the MHRA in case of recalls or safety issues.
MedNet offers UK RP services to assist non-UK manufacturers in complying with the UK regulatory requirements. We guide you through the regulatory process, ensuring that your devices meet the necessary standards for safe and effective use in the UK market.
More Information: UK Market
Why Choose MedNet EC-REP?
Unmatched Expertise
With over 30 years of experience in the healthcare industry, we have partnered with more than 700 manufacturers worldwide. Our deep understanding of the regulatory requirements for medical devices makes us a trusted choice for manufacturers of all sizes and specialties.
Quality Assurance
As an ISO 13485-certified company, MedNet adheres to the highest quality standards. You can rely on us to manage your compliance needs efficiently and professionally.
Global Reach, Local Expertise
While we specialize in the EU market, our services extend to other regions with similar regulatory frameworks, ensuring that your products can reach their target markets without unnecessary hurdles.
Understanding Swiss Regulations for Medical Device Compliance
Switzerland, while not an EU member state, follows a regulatory system that is largely aligned with EU requirements. However, there are still key differences that must be taken into account. The Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for regulating medical devices in Switzerland.
Non-Swiss manufacturers must appoint a Swiss Authorized Representative (CH-REP) to ensure their devices comply with Swiss regulations. The CH-REP plays a critical role in ensuring that manufacturers meet the necessary requirements to place medical devices on the Swiss market.
Key responsibilities of a CH-REP include:
- Ensuring that the medical device complies with Swiss regulations.
- Keeping the necessary documentation for inspection by Swiss authorities.
- Acting as the point of contact between the manufacturer and Swissmedic for regulatory matters.
- Handling safety-related incidents, recalls, and vigilance reports.
MedNet provides CH-REP services for non-Swiss manufacturers, assisting you in meeting Swiss regulatory requirements and ensuring your devices are compliant for the Swiss market.
More Information: Swiss Market
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