If you manufacture medical devices outside the EU, UK or Switzerland, you are required under EU directives and UK / Swiss legislation to appoint a European Authorised Representative (EAR), a UK Responsible Person (UKRP) - a role specifically required since the UK left the European Union - or a Swiss Authorised Representative (CH-Rep). Mandaremed provides all three, plus the regulatory consultancy to support them.
Three Markets. One Trusted Partner.
From the Day You Enquire
Medical device registration is complex and time-consuming. We guide you through every step with clear responsibilities and a fixed quotation.
Discuss Your Project
We scope your project, your products and their device classifications.
Define & Quote
We define what is required, assign responsibilities and provide a quotation.
Review & Agree
We review your technical documentation and certifications, and draft the representative agreements for the relevant authorities.
Market Access
Appointment in place, registrations handled, and ongoing support as your in-market representative.
A Personal Approach That Builds a True Partnership
We stand for a personal way of working that fosters a strong partnership, making the regulatory compliance process smoother and more efficient. We establish a close, collaborative relationship with every customer.
This demonstrates our commitment to meeting regulatory requirements while recognising the real value of our representatives' expertise in achieving your market goals.
- ✓ Direct access to named regulatory specialists
- ✓ Our own staff on the ground in London & Amsterdam
- ✓ Clear, transparent quotations - no surprises
Tailored to Your Products and Your Target Markets
Product compliance and registration steps vary by product type and by the regulatory framework of each market. We give you a clear outline of the typical steps for the EU, UK and Switzerland - and a dedicated consultancy service to advise you on the specific requirements that apply to your devices.
"Product compliance and registration requirements can vary significantly depending on the industry, product type, and the specific regulations of the target market. Consulting with regulatory experts can be instrumental in ensuring a smooth compliance and registration process for your product."
Based Where You Need Us
Mandaremed Ltd.
167-169 Great Portland Street, 5th Floor
London, W1W 5PF, United Kingdom
Tel. +44 020 8050 7864
Mandaremed B.V.
Tijnmuiden 59
1046 AK Amsterdam, The Netherlands
Tel. +31 020 - 30 86 404
Ready to access the EU, UK or Swiss market?
Tell us about your devices - we will respond with a clear scope and quotation.
What is an EAR?
A European Authorised Representative (EAR) plays a crucial role in ensuring that products placed on the EU market comply with the relevant regulations. This role is particularly important for non-EU manufacturers who want to sell their medical devices within the European Union.
Under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), a manufacturer established outside the EU must appoint an authorised representative located within the EU before placing devices on the market. Mandaremed B.V., with staff located in the Netherlands, acts as that representative for you.
What Mandaremed does as your EAR
- ● Verifying that the EU Declaration of Conformity and technical documentation are in order and available to the authorities
- ● Registering your devices in the European database EUDAMED / with the relevant Competent Authority
- ● Acting as the single point of contact for EU Notified Bodies and Competent Authorities
- ● Handling vigilance, incident reporting and field-safety communications on your behalf
- ● Signing a written mandate that defines our shared responsibilities with you as manufacturer
Based in Amsterdam, serving all 27 EU Member States
Mandaremed B.V. · Tijnmuiden 59, 1046 AK Amsterdam · +31 020 - 30 86 404
Why a UKRP?
The United Kingdom Responsible Person (UKRP) became a specific requirement after Brexit, when the UK withdrew from the European Union. A UKRP is a person or legal entity appointed by a manufacturer established outside the UK to represent them in regulatory matters relating to product compliance and registration on the UK market.
For medical devices placed on the market in Great Britain (England, Wales and Scotland), the Medicines and Healthcare products Regulatory Agency (MHRA) requires a UK-based Responsible Person for manufacturers located outside the UK. Mandaremed Ltd., with staff located in the United Kingdom, acts as your UKRP from our London office.
What Mandaremed does as your UKRP
- ● Registering your devices with the MHRA and maintaining your UK device registrations
- ● Ensuring the UK Declaration of Conformity and technical documentation are available to the authorities
- ● Acting as the single point of contact for the MHRA and UK Approved Bodies
- ● Managing UK vigilance and adverse-incident reporting obligations
- ● Advising on the transition between UKCA marking and the evolving UK regulatory framework
Based in central London, covering the whole UK market
Mandaremed Ltd. · 167-169 Great Portland Street, 5th Floor, London W1W 5PF · +44 020 8050 7864
When do you need a CH-Rep?
A Switzerland Representative - also known as a Swiss Authorised Representative (CH-REP) - is required in certain situations for regulatory and compliance purposes. Manufacturers established outside Switzerland who place medical devices on the Swiss market must appoint a representative located in Switzerland.
Swiss medical device law is overseen by Swissmedic. Because Switzerland is not part of the EU, a European Authorised Representative does not cover the Swiss market - a separate Swiss representative is required. Mandaremed uses selected, trusted partners for this task and offers CH-Rep services after an initial consultation to confirm your exact needs.
How our CH-Rep service works
- ● Initial consultation to assess whether a CH-Rep is required for your devices
- ● Appointment of a vetted Swiss representative from our partner network
- ● Coordination of Swissmedic registration and authorisation holder obligations
- ● Single point of contact - you work with Mandaremed; we manage the Swiss partner relationship
- ● Bundled with EAR / UKRP appointments where you need all three markets
CH-Rep is offered after consultation
Contact us to discuss your Swiss market requirements - we will confirm scope and introduce the right partner.
Enquire About Our Services
Complete the form below and your enquiry is sent directly to Mandaremed. We will reply to the email address you provide.
Mandaremed Ltd.
167-169 Great Portland Street, 5th Floor
London, W1W 5PF, United Kingdom
Tel. +44 020 8050 7864
Mandaremed B.V.
Tijnmuiden 59
1046 AK Amsterdam, The Netherlands
Tel. +31 020 - 30 86 404
