The supply of smart and safe devices in the European market is integral to offer better healthcare through innovative solutions. The European Union implemented strict safety requirements to ensure quality and safety before medical device manufacturers, specifically foreign medical device companies, can legally supply medical products in the EU market.
That said, non-EU manufacturers must appoint economic operators to ensure compliance with European regulations. This includes European authorised representatives for medical device companies, who play a crucial role in speeding up the registration process. They help obtain CE certification and carry out conformity assessments.
This article looks into the EU MDR Regulation and the obligations of your authorised representative in undertaking compliance tasks for your medical device distribution in the EU market.
What Is the EU MDR Regulation?
Medical Devices Regulation (EU 2017/745) replaces the Medical Devices Directive (93/42/EEC), or MDD, as the legislation detailing the requirements for manufacturers to place medical devices on the European Union’s market. Unlike the MDD, the EU MDR promotes a life-cycle approach to medical device regulation rather than focusing exclusively on pre-approval.
Scope of the MDR Regulation
The EU MDR Regulation aims to harmonise standards on medical device compliance across all Member States. This regulation is mandatory for all foreign companies that wish to sell or distribute their products on the European marketplace.
Manufacturers must create a suite of MDR-compliant regulatory systems, processes, and documents to monitor their products’ safety and performance. Medical device manufacturers should demonstrate MDR compliance by applying for a CE mark on their medical products.
The EU MDR Authorised Representative
If you are a non-EU medical device manufacturer looking to sell your products in Europe, it can be challenging to ensure your products comply with local policies and regulatory requirements. This is where an authorised representative (AR) comes into the picture.
An authorised representative, as defined in the Medical Device Regulation 2017/745, is any natural or legal entity within the European Union that has accepted a mandate from a non-EU manufacturer to ensure compliance with European Directives when placing medical devices on the European market. The representative must either be a natural-born citizen of the EU or a legal person/entity established within the EU.
Many of the general obligations are outlined in the MDR/IVDR article. The regulations also define the activities that can and cannot be delegated to the authorised representative.
In short, your European AR will act as a liaison between you and the national competent authorities should there be a problem with your product placed in the European market.
What Countries Don’t Need an EU AR?
As long as you comply with the CE marking regulation, you don’t need an authorised representative if you are in a European Union country.
To be specific, if you are a member of the following groups, you are not obligated to have an authorised representative to sell medical devices in Europe:
- EU: European Union
- EEA: European Economic Area
- EFTA: European Free Trade Association
Who Can Appoint an AR?
If you are located outside the European Union and would like CE certification for your medical products or in vitro diagnostic devices (IVDs) intended for sale in Europe, you need to hire an AR.
You must understand the importance of working with an authorised representative (AR) and how their roles and responsibilities change. Furthermore, you should make sure that your chosen AR has the means to implement and adhere to new regulatory requirements for your medical device’s compliance.
What Does an EU MDR Authorised Representative Do?
Under the EU MDR regulations, your AR will represent you in the following:
1. Documentation check
Your MDR-authorised representative will verify the device’s declarations of conformity. They will review the technical documentation and make this documentation available to the Member States’ competent authorities upon inspection.
2. Registration check
The AR will verify that you comply with the Unique Device Identification (UDI) registration, ensuring that your products are correctly labelled, and registration of medical devices is complete. Moreover, authorised representatives will have to verify you have registered the requested information in EUDAMED.
3. Audit support
The authorised representative should also inform you of any requests from the competent authorities and ensure that all necessary information, documentation, and samples are provided and received.
They should also respond should medical incidents occur to mitigate the risks posed by your devices.
4. Vigilance report
The representative should immediately inform you of any complaints or reports from healthcare professionals, patients or users regarding suspected product incidents.
5. Compliance
The representative can terminate the mandate when the manufacturer acts contrary to its obligations under the regulation. The representative will also be held liable for defective devices due to non-compliance.
An AR should notify the competent authorities and the notified body if a certification has been terminated. Additionally, the AR should specify the reason for the termination.
6. Administrative tasks
A medical device manufacturer can delegate an activity related to specific national notification requirements. Most importantly, these national laws must be clearly outlined in the agreement between the manufacturer and the representative.
In Conclusion
Medical devices play a huge role in the healthcare sector in diagnosing and treating, and preventing or predicting diseases or disorders. Patients can access high-quality, safe, and effective medical devices with registered and compliant medical devices. By conforming to statutory requirements implemented by the European Union, health safety is improved for patients, healthcare workers and the community.
Do You Need an Authorised Representative?
Are you a medical device company planning to place your products on the European market? Vicki Partridge can help.
Vicki has an extensive background in the medical device industry. Her expertise in medical device regulatory affairs can help you better understand the role and responsibilities of an EU MDR-authorised representative and why appointing one is essential.
Contact her office at +61 7 55295508 or email at vicki@vickipartridge.com.au.