EU Authorized Representative | OMC – US, UK, China & More
Engaging with EU MDR, IVDR and CE Marking
Need an EU Authorized Representative? OMC supports MDR/IVDR compliance for medical devices in the US, UK, China, Japan, Mexico, India, Korea & Russia.
OMC Medical EU – Your Gateway to Regulatory Success
At OMC Medical, we specialize in assisting medical device manufacturers in navigating the European Union’s stringent regulatory framework. With expertise in EU MDR (2017/745), IVDR (2017/746), and EU Authorized Representative (EUAR) services, we ensure a seamless approval process for your products. Whether you need support with device registration, technical documentation, local representation, quality assurance, clinical evaluation, or post-market surveillance, our dedicated team in the EU provides comprehensive regulatory solutions. Trust OMC Medical to help you achieve compliance and successfully enter the European medical device market
OMC Benefits
- Regulatory Expertise: Over 10+ years of experience in EU MDR (2017/745) & IVDR (2017/746) compliance.
- Faster Market Entry: We streamline the device registration and approval process, ensuring a smooth entry into the EU market.
- Direct Communication with EU Authorities: We act as your official point of contact with Notified Bodies & Competent Authorities.
- Comprehensive Compliance Support: From technical documentation review to post-market surveillance, we handle all regulatory requirements.
- Legal Representation & Risk Mitigation: We help you stay compliant, avoid penalties, and minimize market access risks.
- All EU Markets Covered: Our services extend to all 27 EU member states, ensuring complete market access.
Ensure EU Compliance & Expand Your Business – Partner with OMC Medical Today
Discover tailored solutions across pharmaceuticals, life sciences, consumer goods, and more. Our expertise spans diverse industries, ensuring compliance and excellence. Explore innovative strategies and services to elevate your business in the competitive market
The EU’s medical device and IVD market is strictly regulated under EU MDR (2017/745) and IVDR (2017/746), requiring full compliance for market approval. OMC Medical simplifies this process by providing expert assistance in CE marking, EU Authorized Representative (EUAR) services, device registration, supplier audits, QMS implementation, process validation, and regulatory documentation. Our services ensure smooth market entry, ongoing compliance, and a strong competitive position in the EU’s evolving healthcare sector.
The EU’s cosmetics market is regulated under the EU Cosmetics Regulation (EC) No 1223/2009, requiring strict compliance for product registration, safety assessments, labeling, and market surveillance. OMC Medical streamlines this process by offering expert guidance in EU Authorized Representative (EUAR) services, regulatory approvals, local representation, supplier audits, and ongoing compliance management. We help brands navigate the EU’s evolving cosmetic regulations, ensuring seamless market entry and long-term success.
The EU’s pharmaceutical market is regulated under EMA and national competent authorities, requiring strict compliance for drug registration, clinical trials, quality control, and post-market surveillance. OMC Medical simplifies this process by providing expert support in EMA approvals, EU Authorized Representative (EUAR) services, GMP compliance, supplier audits, and regulatory documentation. We help pharmaceutical companies navigate the EU’s evolving regulatory landscape, ensuring smooth market entry and sustained compliance
OMC Medical provides expert support for businesses seeking market entry in the EU by acting as an EU Authorized Representative (EUAR) and ensuring compliance with EU MDR & IVDR regulations. We assist with regulatory submissions, appointing an EUAR, and managing communications with EU authorities. Our expertise in the EU’s evolving regulatory landscape ensures a smooth approval process, enabling seamless market access for medical devices, pharmaceuticals, and cosmetics
OMC Medical provides expert translation services tailored to the EU’s regulatory landscape, ensuring compliance with EU MDR & IVDR requirements. As an ISO 17100:2015 certified provider, we specialize in accurate translations of medical, pharmaceutical, and clinical documents, including IFUs, user manuals, and legal texts. Our services help businesses navigate regulatory approvals and facilitate seamless market entry across the EU
Expand Your Medical Device Business in Europe
Are you a medical device manufacturer looking to sell in the EU market? You must appoint an EU Authorized Representative (EUAR) to comply with EU MDR & IVDR regulations and obtain CE marking.
We provide expert EUAR services for both large enterprises & small manufacturers, ensuring smooth EU regulatory compliance, product registration, and adherence to ISO 13485 standards
About OMC
OMC Medical is a leading regulatory consulting firm specializing in global market access for medical devices, IVDs, pharmaceuticals, and cosmetics. With expertise in EU MDR & IVDR regulations, we assist businesses in navigating the EU’s complex compliance landscape, including CE marking, product registration, quality assurance, and EU Authorized Representative (EUAR) services.
Our tailored solutions ensure smooth approvals and seamless market entry, making OMC Medical a trusted partner for regulatory success in the European market
What is an EU Authorized Representative?
An EU Authorized Representative (EUAR) is a legal entity based in the European Union that acts on behalf of non-EU medical device manufacturers to ensure regulatory compliance under EU MDR (2017/745) and IVDR (2017/746)
Looking for a Reliable EUAR Partner?
1: Regulatory Compliance
- Ensure technical documentation, conformity assessments, and EU MDR/IVDR compliance.
2: Legal Representation
- Act as the contact point between manufacturers and EU authorities
3: Device Registration
- Assist in EUDAMED registration and CE marking
4: Post-Market Surveillance
- Maintain technical documentation, handle incident reporting, recalls, and PMS.
5: Labeling & UDI Compliance
- Verify IFU, UDI, and ensure correct EUAR details on packaging
6: Notified Body Support
- Assist in conformity assessments and CE certificate renewals
7: Legal Liability
- Share responsibility for product defects and ensure liability insurance.
8: Compliance Monitoring
- Keep regulatory documentation updated and track MDR/IVDR changes
We are a global firm and we have local expertise across the following countries.
Europe
Asia
Africa
Oceania
South America
North America
Responsibilities of an EU Authorized Representative (EUAR)
- To place a medical device on the EU market, manufacturers based outside the EU must appoint an EU Authorized Representative (EUAR)
- The EUAR must provide written evidence of the manufacturer’s authorization to act on their behalf. Importers and distributors are not required to appoint an EUAR
- EU Countries Covered: All 27 EU Member States
- Recognition by Notified Bodies & Competent Authorities.
- Experience Handling Class I, IIa, IIb & III Medical Devices
- Want to Sell in Europe? Let’s Make It Happen
Our EU Authorized Representative Services
- Device Registration & Regulatory Compliance
- Technical Documentation Review & Submission
- Communication with EU Authorities & Notified Bodies
- Labeling & UDI Compliance
- Post-Market Surveillance & Incident Reporting
- Vigilance & Complaint Handling Support
- Want a Smooth Market Entry?
Who Needs an EU Authorized Representative?
- Medical Device Manufacturers outside the EU, UK, and EEA.
- Companies looking to market devices in the EU without a physical presence.
- Businesses that need regulatory compliance and post-market surveillance support
Why Choose Us as Your EU Authorized Representative?
- Over 10+ Years of Experience in EU Medical Device Compliance
- Direct Communication with EU Authorities on Your Behalf
- Faster Market Entry with Compliance Support at Every Step
- Complete MDR & IVDR Compliance Support from Registration to Post-Market Surveillance
Ensure Compliance & Expand Your Reach
How an EU Authorized Representative Helps You
With OMC Medical (EUAR): ✅ Yes
Without an EUAR: ❌ No
With OMC Medical (EUAR): ✅ Yes
Without an EUAR: ❌ No
With OMC Medical (EUAR): ✅ Yes
Without an EUAR: ❌ No
With OMC Medical (EUAR): ✅ Yes
Without an EUAR: ❌ No
Stay Compliant & Avoid Market Restrictions
EUDAMED
Registration
Authorized Representative
EU/MDR Virtual
Importer
Technical
Document
Quality
Assurance
Why Work With Us?
- Trusted by medical device manufacturers worldwide
- Expert regulatory consultants with a proven track record
- Quick turnaround time for EU registration & MDR approvals
- 100% compliance assurance with EU MDR & CIVDR
Have a Business Query? Let us Talk
Frequently Asked Questions (FAQ)
Still Have Questions? Contact Us Now for a Free Consultation
EU regulations require medical device manufacturers located outside the European Union to appoint an EUAR to place their products on the market. Without one, manufacturers cannot legally sell in the EU
- Maintains regulatory documents & technical files
- Facilitates communication with EU regulatory authorities
- Ensures compliance with MDR/IVDR requirements
- Supports incident reporting & post-market surveillance
- Assists with device registration & labeling requirements
Manufacturers must sign a formal agreement with an EU-based entity that clearly defines the EUAR’s responsibilities. The representative’s details must also be included on product labeling.
While some distributors may offer representation, it is generally recommended to appoint an independent EUAR to avoid conflicts of interest and ensure unbiased regulatory support.
Still Have Questions? Contact Us Now for a Free Consultation