Representative Services

Q: What is meant by having a UKRP for medical devices?

The UKRP is a legal entity appointed to ensure compliance with regulatory requirements for medical devices in the UK market.

Q: Why do I need a UKRP?

Having a UKRP is mandatory for all manufacturers base outside the UK wanting to sell in the UK, to fulfill post-Brexit legal obligations and ensure your medical device meets the UK standards.

Q: What are the responsibilities of a UKRP?

The UKRP is responsible for device registration, overseeing device compliance, maintaining technical documentation and communicating with regulatory authorities on behalf of MedTech manufacturers.

Q: How can Apotech support as a UKRP?

We provide expert guidance, perform regulatory tasks, and act as the liaison between you and UK authorities, ensuring a smooth market entry for your medical devices.

Q: What is an importer in Northern Ireland?

You’ll become an ‘importer’ if you’re the one bringing goods for the first time into Northern Ireland from either Great Britain or another non-EU country and placing them on the Northern Ireland market. Only businesses established in Northern Ireland or a European Economic Area (EEA) state can act as ‘importers’ for the Northern Irish market.

Q: What is meant by an EUAR for medical devices?

An EUAR is a designated entity that acts on behalf of non-EU-based MedTech manufacturers to ensure compliance with European medical device regulations.

Q: Why is an EUAR necessary for medical device manufacturers outside the EU?

An EUAR is essential to meet regulatory requirements, facilitate market access, and serve as a point of contact with European authorities for non-EU manufacturers.

Q: What are the key responsibilities of an EUAR?

Some of the main responsibilities of working as an EUAR include representing you as the manufacturer, maintaining technical documentation, assisting with regulatory compliance and acting as your point of contact for EU authorities.

Q: How can Apotech assist as an EUAR?

As an approved EUAR on EUDAMED, our team at Apotech has substantial expertise in regulatory compliance and can act as your designated representative in the EU to seamlessly communicate with EU authorities on your behalf. EUDAMED SRN NUMBER: FR-AR-000039455

Enhance regulatory compliance of your Medical Devices, In Vitro Diagnostic (IVD) or Cosmetics products by selecting Apotech as your UK Responsible Person, European Union Authorised Representative or Person Responsible for Regulatory Compliance.

UKRP

EU AR

PRRC

Rep for in Other Countries

Enabling global market access to medical devices and IVD manufacturers

Trust Apotech as your regulatory partner.

At Apotech, we have global expertise spanning markets including the UK, European Union, and the United States. So if you’re looking to expand into international markets, we can act as your regulatory partner.

We specialise in providing comprehensive authorised representative and importer services to medical devices and IVD manufacturers around the world. Depending on the market you’re looking to access, we can proudly act as either your UK Responsible Person (UKRP), EU Authorised Representative (EUAR) or Person Responsible for Regulatory Compliance (PRRC).

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Our range of representative services

At Apotech, we can help you ensure complete compliance when entering into new markets around the world by acting as your regulatory representative.

Whether it be acting as your UKRP, EUAR or PRRC, we can work with you to make sure your products meet the strict standards set by regulatory bodies specific to each target market.

Our Global Representation Reach

We are dedicated to our clients’ global expansion. With consultants in situ in every major economy, we are well equipped to support your global expansion from a technical standpoint and facilitating local representation.

Apotech is a registered UK Responsible Person (‘UKRP’) for those looking to sell their devices in the UK, and a European Union Authorized Representative you were looking to gain a CE Mark in the EU.

Added to this, work with us to benefit from our combined 15+ years of tried and tested relationships with representative partners globally. Click your desired country below to see how we can support your global expansion…

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Portfolio of 50 devices managed on behalf of 20 clients

Why choose Apotech for representative services?

Our experienced consultants understand the importance of ensuring regulatory compliance within the medical device industry.

Through this ongoing commitment, we have already helped seamlessly guide over 120 MedTech & IVD manufacturers through the intricate web of global regulations.

We offer a global reach.

With consultants available in every major global country, we can provide tailored advice and guidance to represent you wherever you’re based.

We’re experienced.

Our SMEs have a minimum of 20 years of experience and have helped more than 120 MedTech manufacturers bring their medical devices and IVD products to market.

We provide competitive pricing.

Our pricing model is competitive, guaranteeing professional representation that you can trust with no hidden costs.

We speak your language.

Wherever you are in the world, our consultants operate in a wide range of countries and can communicate with you in your local language.

UKRP FAQs

What is meant by having a UKRP for medical devices?

Why do I need a UKRP?

What are the responsibilities of a UKRP?

How can Apotech support as a UKRP?

Does Apotech provide any representative services for Northern Ireland?

Since 26 May 2021, the EU MDR has applied in Northern Ireland and the EU IVDR has applied in Northern Ireland since 26 May 2022.

Therefore, when placing devices on the Northern Ireland market, Great Britain-based and non-EU manufacturers must appoint an EU or Northern Ireland-based Authorised Representative. We can do this for you, acting as your designated EUREP to support market access.

What is an importer in Northern Ireland?

EUAR FAQs

For any further questions please contact us.

What is meant by an EUAR for medical devices?

Why is an EUAR necessary for medical device manufacturers outside the EU?

What are the key responsibilities of an EUAR?

How can Apotech assist as an EUAR?

Can MedTech manufacturers outsource their PRRC?

Yes, for micro-manufacturers and small companies, it is possible to outsource the PRRC role to an outside expert. The micro or small enterprise may subcontract the responsibilities of a person responsible for regulatory compliance to a third party, so long as the qualification criteria are met and the manufacturer can demonstrate and document how they can meet their legal obligations.

Can you also act as an authorised representative for cosmetic products?

Yes, our team can also act as your authorised representative if you work in the cosmetics industry.

Registered with both the European Commission and MHRA, we can notify your cosmetic products on the relevant portal, whether that be the CPNP or SCPN portal. Acting under a legal mandate, we would review your product information file, control the relevant labelling, notify the target market (EU or UK) and endorse the responsibility of the responsible person.

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