Mandaremed
We act as 'Authorized Representatives' in both EU, UK and Switzerland providing Quality and Regulatory services to support your access requirements to these markets.
More about usMandaremed
Quality & Regulatory Specialists
If you manufacture products outside the EU, UK or Switzerland you are required under the EU directives, UK Legislation to appoint an European Authorized Representative (EAR), United Kingdom Responsible Person (UKRP who is specifically required since the UK left the EU BREXIT) or Swiss Authorized Representative.
Mandaremed can act as your Authorized Representative or Responsible Person in both Europe and also within the UK having staff located in the Netherlands and UK.
You could utilize the services of a distributor instead to represent your company and using a distributor may seem like the easiest option, but it may not be the right choice. Here at Mandaremed we believe by being your representative you will benefit by being able to fully mantain control of the activities that are important to you such as marketing your products within the EU, UK and CH.
Established in 2023 and employing regulatory specialists with over 30 years of experience in quality and regulatory affairs who are passionate about the work they do and providing excellent levels of customer service and support.
YOU CAN RELY ON US
From the day you enquire...
Medical device registration is a critical process that involves obtaining regulatory approval to sell medical devices in various markets around the world. It can be a complex and time-consuming endeavor, and many companies choose to work with specialized service providers to assist with medical device registration. These service providers offer expertise in navigating the regulatory landscape and can help ensure that your medical devices meet all the necessary requirements.
We will be able to discuss the scope of your project, the different products and classifications of your devices. What will be required, defining responsibilities and providing you with a quotation for the work requested.
Next steps
Choosing the right medical device registration service provider is crucial to ensuring a smooth and successful market entry for your medical devices. Make sure to carefully evaluate providers based on their expertise, track record, and the specific services they offer to meet your regulatory needs. Additionally, consider the geographical regions where you plan to market your medical devices, as regulatory requirements can vary significantly between countries and regions.
We will start to work with you, reviewing your technical documentation / certifications and discuss the creation of the necessary agreements between you as manufacturer and us for the respective health authorities.
Why us
We stand for a personal approach to working that fosters a strong partnership, making the regulatory compliance process smoother and more efficient. It demonstrates our commitment to meeting regulatory requirements while also recognizing the value of our AR's expertise and assistance in achieving your market goals. It is particularly relevant for us to establish a close and collaborative working relationship with our customers.
Customized solutions
Product compliance and registration steps can vary depending on the type of product and the regulatory framework in your specific region or market. However, we can provide you with a clear outline of the typical steps involved in ensuring product compliance and registration within these markets.
OUR SOLUTIONS FOR YOU
EU Authorized Representative (EAR)
An Authorized Representative (AR) in the context of the European Union (EU) plays a crucial role in ensuring that products placed on the EU market comply with relevant regulations. This role is particularly important for non-EU manufacturers who want to sell their products in the EU.
United Kingdom Responsible Person (UKRP)
A United Kingdom Responsible Person (UKRP) is a term that may have become more relevant post-Brexit, as the United Kingdom (UK) withdrew from the European Union (EU). The UKRP is typically a person or organization appointed by a manufacturer located outside the EU to represent them in regulatory matters related to product compliance and registration
Swiss Authorized Representative (CH-REP)
A Switzerland Representative, also known as a Swiss Authorized Representative (CH-REP), is required in certain situations for regulatory and compliance purposes.
“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 and authorities in your industry can be instrumental in ensuring a smooth compliance and registration process for your product."
Mandaremed
Identifying Applicable Regulations
Documentation Preparation
Registering with Regulatory Authorities
Incident Reporting and Post-Market Surveillance
GET IN CONTACT
Address
Mandaremed BV
Tijnmuiden 59
1046 AK Amsterdam
The Netherlands
Madaremed Ltd
167-169 Great Portland Street
5th Floor, London
W1W 5PF - UK
European Authorized Representative / CH-REP
United Kingdom Responsible Person (UKRP)
All Authorized Representative Enquiries (EU / UK / CH)
info@mandaremed.com