Representative Services
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.
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).
Trusted by top-tier teams worldwide
UK Responsible Person (UKRP)
MHRA Account Number: 20552
In the post-Brexit era, and following the introduction of the UK MDR (2002), adhering to guidelines set by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) regulations is vital.
At Apotech, we understand the complexities of regulatory compliance for medical devices in the UK and can guide you through the process. Working as your UKRP, we will take on specific responsibilities to ensure your products meet the highest standards set by the MHRA.
This includes:
- Device registration: We will register all your devices with the MHRA before they are placed on the market and update any details accordingly.
- Regulatory oversight: We will ensure that your devices comply with the latest regulatory requirements (UK MDR 2002).
- Technical documentation management: We maintain and manage the technical documentation required to demonstrate compliance with applicable standards, providing a foundation for regulatory submissions.
- Market surveillance expertise: Our team implements rigorous processes to monitor and report any incidents, field safety notices (FSNs) or recalls promptly to the MHRA. We can also help you draft Periodic Summary Reports (PSR) and Trend Reports.
- Suspected incidents: We will immediately inform you about complaints and reports from healthcare professionals, patients and users about any suspected incidents.
- Point of contact: Our team serves as your primary point of contact with the MHRA, fostering open communication and facilitating regulatory interactions on your behalf.
- Collaboration with authorities: We actively cooperate with regulatory authorities, providing access to documentation and supporting any necessary assessments to ensure a smooth regulatory journey.
- Product labelling: Apotech details will be included on the product labelling, outer packaging or instructions for use upon agreement of a written contract.
EU Authorised Representative (EUAR)
EUDAMED SRN NUMBER: FR-AR-000039455
The EU MDR states that any natural or legal person established within the European Union can act as an authorised representative for a MedTech manufacturer, so long as you are located outside the EU and provide a written mandate.
Our team at Apotech can perform this role for you, offering seamless access to the European market by acting as your EU authorised representative (EUAR) or Person Responsible for Regulatory Compliance (PRRC).
Using the experience and expertise of our in-house consultants, we can help ensure your medical devices meet the requirements set by both the EU MDR and IVDR. We can also offer support with:
- Legal representation: Serving as your legal representative within the EU, our team can ensure your medical devices or IVD products comply with EU regulations.
- Regulatory compliance oversight: By meticulously navigating the complexities of the European regulatory landscape, we can make sure your devices comply with the relevant legislation.
- Technical documentation management: We can take charge of managing and maintaining your technical documentation.
- Communication with competent authorities: As your local point of contact, we can communicate with competent authorities on preventative and corrective actions, and inform you about any complaints or requests for samples of devices.
- Incident reporting and vigilance: We coordinate the reporting of incidents and field safety corrective actions to the relevant competent authorities in the EU, ensuring timely and compliant submissions.
- Post-market surveillance: Our team actively engage in post-market surveillance activities, monitoring the safety and performance of your medical devices after they have been introduced into the European market.
- Labelling and information compliance: We ensure that the labelling of your medical devices and accompanying information meet the EU regulatory standards to facilitate a smooth market entry.
- Device registration: Our team will verify and ensure your medical devices are appropriately registered on EUDAMED.
Person Responsible for Regulatory Compliance (PRRC)
A new role introduced by Article 15 of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), manufacturers and their authorised representatives must now also have a person responsible for regulatory compliance (PRRC).
This new role is designed to ensure that the supervision and control of the manufacture of devices, including any post-market surveillance or vigilance activities, are carried out within the manufacturer's organisation by a qualified individual.
Having a PRRC applies to:
- Manufacturers established within the EU
- Manufacturers established outside the EU
- Manufacturers looking to place devices into the EU market
- Authorised representatives of non-EU manufacturers
At Apotech, our consultants at Apotech Consulting France can act as your PRRC to ensure complete compliance with the regulatory requirements expected of you throughout the entire lifecycle of your medical device or IVD product.
Representative Services in Other Countries
To complement our in-house UK and European services, we have established partnerships in most of the countries where a local representative is required.
So if you require a representative to market your MedTech device locally, we can support you in your journey, wherever you are based in the world.
Excited to work together on your next project?
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…
of submissions approved first time
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.