Medical Device Authorized Representative

Bring Your Medical Devices to the EU, UK & Swiss Markets

Entering these markets requires the right local regulatory representation. Our experts support your organization as your Authorized Representative, Swiss Representative, or UK Responsible Person, helping you meet local requirements and maintain access to your target markets.

Keep Your Local Regulatory Obligations Covered

Regulatory Authority Liaison

Maintain a local point of contact for the relevant authorities and receive support with regulatory communications concerning your medical devices.

Support applicable device registration activities and help ensure the required manufacturer and product information is properly submitted.

Help ensure required regulatory documentation is available and support your organization when authorities request information or evidence.

Receive local support for applicable vigilance, incident reporting, safety actions, and other post-market regulatory obligations.

Medical device Authorized Representative services for manufacturers entering the EU, UK, and Swiss markets.

One Partner for Your Key European Markets

Access the local representation your medical device business needs to enter and maintain access to the EU, Swiss, and UK markets.

EU Authorized Representative for medical devices

EU Authorized Representative

Establish your required presence in the European Union with an EU Authorized Representative who acts as your regulatory contact and supports your obligations under the MDR or IVDR.

Swiss Authorized Representative CH-REP for medical devices

Swiss Authorized Representative (CH-REP)

Meet Swiss representation requirements with a CH-REP who supports communication with Swiss authorities and helps you maintain regulatory compliance in Switzerland.

UK Responsible Person UKRP for medical devices

UK Responsible Person (UKRP)

Access the UK market with a UK Responsible Person who represents your organization with the MHRA and supports applicable medical device registration and regulatory obligations.

Local Representation Made Simple

Entering a new market shouldn’t mean building a local regulatory department. We help establish the representation you need and work alongside your organization to support your ongoing obligations in the EU, Switzerland, or the UK.

1. Understand Your Market Needs

We review your devices, target markets, manufacturer location, and regulatory status to determine the representation requirements that apply to your organization.

2. Establish Your Local Representation

We put the appropriate representation in place, whether you need an EU Authorized Representative, Swiss Authorized Representative (CH-REP), or UK Responsible Person (UKRP).

3. Support Your Ongoing Obligations

Once your representation is established, we remain your local regulatory contact and support applicable registrations, authority communications, documentation requests, and post-market obligations.

Expand Internationally Without Building Local Operations

Entering new markets can require local regulatory presence, additional resources, and ongoing coordination. Our representation services give you the local regulatory infrastructure you need while your team stays focused on your products and business.

No Local Entity Required

Meet applicable representation requirements without establishing and managing your own company or office in each market.

Reduce Internal Workload

Let our team handle representative-related activities so your internal regulatory resources can stay focused on higher-priority work.

Simplify Multi-Market Management

Work with one regulatory partner instead of managing separate relationships and processes as you expand across European markets.

Scale as Your Business Grows

Add representation for new products and markets as your international business develops, without building additional internal infrastructure.

Establish the Local Presence Your Business Needs