Article 13 MDR/IVDR Regulatory Importer Service

It’s a New EU Requirement

This is a new regulatory role under the MDR/IVDR and comes into play when the Manufacturer is located outside the EU. The Importer is responsible for placing devices on the EU market and must verify that the Manufacturer is in full compliance with the regulations. We offer a virtual importer service so the way you ship to the EU can remain unaffected. All checks and document reviews by Advena Services Ltd are completed remotely.

It’s a Critically Important Regulatory Role

The Importer plays a pivotal role in ensuring the compliance of devices produced by manufacturers who are located outside the EU but the Regulations do not make it mandatory for the manufacturer to appoint an Importer. However, when an importer is not appointed or identified, the default position is that the entity receiving the shipment in the EU automatically becomes responsible for Article 13, and the obligations of these Regulations rest (sometimes unknowingly) with the receiving entity. This also means that the Manufacturer may then be obliged to disclose sensitive information to an entity it would not necessarily have chosen to do so.

Appointing the Right Partner is Crucial

Advena Services Ltd was set up specifically to answer the needs of medical device manufacturers who are struggling to find a suitable partner without disrupting their well-established supply-chain and logistical routes to shipping to the EU. The Article 13 MDR/IVDR Regulatory Importer service provided by Advena Services Ltd, meets the obligations as set out in Article 13 of the MDR and the IVDR. We also help by providing clients guidance, opinions, professional advice and vital regulatory news updates, all designed to help clients understand compliance.

Since the initial legal act places the importer in the chain of liability, you should make sure your importer carries the requisite level of product liability insurance.

Experienced & Qualified

Advena Service Ltd benefits from over 25 years of regulatory experience by being part of the Advena group of companies and employs qualified individuals who possess the necessary expert knowledge of the regulatory requirements for medical devices. This knowledge is supported by academic qualifications and professional experience in regulatory affairs and quality management relating to medical devices.

Regulation (EU) 2017/745, the MDR & (EU 2017/746), the IVDR has introduced the regulatory role of Importer, one of four key roles in medical devices reaching and being sold in the EU, so how does this work?

For this example, we will assume the manufacturer is based in Australia (a third country) selling medical devices to the EU and they are satisfied that they are compliant with the MDR or IVDR as applicable. And they have their:

Technical Documentation.
Declaration of Conformity.
CE Certificate (if applicable).
IFU.
Labelling.
And an EU Authorised Representative has been appointed.

The manufacturer is ready to ship their order to the EU but now needs a regulatory Importer to carry out its verification checks.

The Importers role is to check that the manufacture has met their regulatory obligations and verifies this by following the requirements laid out in article 13 of the MDR/IVDR.

The service offered by Advena Services Ltd allows the manufacturer to use their well-established logistical routes when to shipping to the EU. In this way, once the shipment arrives it is considered placed on the market and the distributor can move on to the next step of making devices available.

The Importer is responsible for placing devices on the market and has significant responsibilities to verify that the manufacturer is compliant with the regulations, this means there are a multitude of tasks to perform to verify regulatory compliance.

However, while physical checks are a tool that can be used by a regulatory importer Advena Services Ltd will verify all documents pertaining to a shipment remotely.

This has the benefit of meeting the regulatory requirements of the Importer without disrupting the manufacturer’s well-established supply chain and logistical routes to shipping to the EU.

The manufacturer just needs to ensure the Importer has completed its regulatory obligations
before shipping to the EU.

That devices have been CE marked.
Applicable Declarations of Conformity have been drawn up.
The technical documentation exists.
Device labelling identifies the Manufacturer, Authorised Representative and Importer contact details.
Where applicable, UDI information is present.
Instructions for Use and accompanying information are with the device.
That devices are registered with EUDAMED in accordance with Article 29 (MDR) and/or Article 26 (IVDR).
Where applicable and in accordance with the Regulations, translated labelling and Information for Use is provided.
MDR/IVDR device storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I.

Keep a record of complaints.
If applicable, report incidents and/or serious risks to Competent Authorities and cooperate as required.
Keep available declarations of conformities and certificates for inspection by the authorities.
Carry the requisite level of product liability insurance since under EU law the Importer is jointly and severally liable with the manufacturer for defective devices, they may place on the market

Why Choose Advena as Your EU Article 13 MDR/IVDR Regulatory Importer?

By appointing Advena Services Ltd as your EU Article 13 MDR/IVDR Regulatory Importer you are engaging with a group of companies who have a wealth of experience in regulatory affairs representing a worldwide client portfolio. We offer a premium service at a competitive price, supporting clients to navigate the complex regulatory landscape in the EU.

Over 25 years’ experience in regulatory affairs.
We comply with Article 13 of the MDR & IVDR.
Our service doesn’t disrupt your well-established supply-chain and logistical routes to shipping to the EU.
We carry out our verification obligations quickly and efficiently.
Our QMS is certified to ISO 13485

We are responsive, 90% of emails are replied to within 24-48 hours.
You will receive our monthly regulatory newsletter that helps you keep up to date with the changes in regulations and standards.
We offer a premium service at a competitive price.

Years of experience

Advena Services Ltd benefits from over 25 years of regulatory experience by being part of the Advena group of companies and employs qualified individuals who possess the necessary expert knowledge of the regulatory requirements for medical devices. This knowledge is supported by academic qualifications and professional experience in regulatory affairs and quality management relating to medical devices. This makes us the ideal choice for your business.

Personal approach

We have a team of professionals who have the depth of knowledge needed to carry out the Importer obligations, our team provides a personal approach dedicated to placing the needs of our clients at the very top of our priorities while also recognising that the applicable EU regulations must be complied with. Just take a look at our Testimonial Page.

Great Responsive support

Advena efficiently carries out its verification obligations before the manufacturer ships to the EU without disrupting well established logistical routes. We also understand that clients need to be able to reach out for help and advice and how important being responsive is, Advena is committed to supporting our clients and is always available to answer clients’ questions and queries, and this is included as standard in our service. In fact, our client feedback survey found that 90% of emails were replied to within 24-48 hours.

The 5 Simple Steps to Appoint Advena

Professional service and quick response

We have been using Advena Ltd. as our EU Authorised Representative since 1998 and have been very pleased with the professional service and quick response… “Professional service and quick response”

Quality of services

I have used Advena as part of another company and I have contracted them again for the quality of services and reasonable fees. The newsletter… “Quality of services”

Very positive experience.

Always responsive and willing to work with us. Has gone above and beyond on a number of occasions, and that has been very helpful when… “Very positive experience.”

Well informed

Advena have acted as the EU representative for Aus Systems Pty Ltd since 2005. I have always found John and his team quick to respond… “Well informed”

Fully professional and supportive

I have worked with Advena on the Regulatory side of our business now for more than 10 years. The service provided during this time has… “Fully professional and supportive”

For More Information Concerning Our Article 13 MDR/IVDR Regulatory Importer Service that:

Complies with Article 11 of the MDR & IVDR.
Carries our verification obligations quickly and efficiently.
Is cost effective.
Has a QMS certified to ISO 13485

Offers regulatory guidance and opinion.
Answers your questions in a responsive manner.
Allows you to benefit from our extensive experience and knowledge.
Doesn’t disrupt your well-established supply-chain and logistical routes to shipping to the EU.