If you are a non-EU manufacturer, you must comply with the Medical Device Regulation (MDR). The Regulation states that manufacturers must select an importer to meet the requirements and be liable and responsible for placing products on the EU market.
At the end of the day the manufacturer remains responsible and liable for the supply chain stated in the MDR/IDR, 2017/745. Therefore, manufacturers must revisit their importer partner and structure to guarantee compliance.
GrowthImports is an independent European wide MDR compliant importer that provides hassle-free, cost-effective importing services while allowing our clients to maintain full control and flexibility.
What is a Definition of MDR Importer?
According to the Blue Guide / MDR the definition of the Importer is “Any natural or legal person established within the Union that places a device from a third country on the Union market”. A product is placed on the market when it is made available for the first time on the Union market.
A product is made available on the market when supplied for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge. (46) Such supply includes any offer for distribution, consumption or use on the Union market which could result in actual supply (e.g. an invitation to purchase, advertising campaigns).
Supplying a product is only considered as making available on the Union market, when the product is intended for end use on the Union market. The supply of products whether for further distribution, for incorporation into a final product, or for further processing or refinement with the aim to export the final product outside the Union market is not considered as making available. Commercial activity is understood as providing goods in a business related context.
As for ‘making available’, the concept of placing on the market refers to each individual product, not to a type of product, and whether it was manufactured as an individual unit or in series. Consequently, even though a product model or type has been supplied before new Union harmonization legislation laying down new mandatory requirements entered into force, individual units of the same model or type, which are placed on the market after the new requirements have become applicable, must comply with these new requirements.
Who can be your Importer?
The operation is reserved either for a manufacturer or an importer, i.e. the manufacturer and the importer are the only economic operators who place products on the market. When a manufacturer or an importer supplies a product to a distributor or an end-user for the first time, the operation is always labelled in legal terms as ‘placing on the market’. Any subsequent operation, for instance, from a distributor to distributor or from a distributor to an end-user is defined as making available.
You as the manufacturer can also be the importer if your have an EU entity. There are benefits in outsourcing the importing, however when having an entity it is an option. If you are selling goods through online resellers such as Amazon or other e-commerce sites and if they are selling to the end-users they should also be seen as the MDR importer.
Your Distributor as your Importer?
In the context above it would make your distributor your importer. You can also choose to have multiple distributors as your importer. Be aware that distributors have different obligations than importers. That would mean your distributor needs to comply with importer obligations.
It brings substantial risks of incompliance as well as potential complications and market conflicts if you assign your distributor as your importer. You can read this article to understand the complications and risks when you assign your distributor as your importer and why it may be more beneficial to assign an independent importer.
How to verify a MDR compliant importer?
Now it is clear who can be the MDR importer it is important to understand the risks and benefits of choosing your importer as the manufacturer will in any case be liable for incompliance in the supply chain. In the article above the complications involved when selecting your type of importer is mentioned.
Once you have selected your importer it is important to check whether your importer is able to comply with the obligations. It is vital to understand their capabilities, what is their knowledge, how will you audit your importer, how have they structured their regulatory department, how will they keep compliance, what is their auding and inspection procedure as an importer is responsible to verify products placed in the European market are MDR compliant. These are questions that should be asked and assured in a contract.
The Importer Needs to Fulfill the Following Obligations:
- A natural or legal person established in the European Union
- Registered and verified by the local authorities
- Ensure the appropriate conformity assessment procedure has been carried out by the manufacturer
- If the importer has reasons to believe about the conformity of the product the importer must refrain from placing in the market and shall immediately take the corrective measures necessary to bring that product into conformity and with risks involved inform the CA
- When placed on the market taking corrective actions
- The manufacturer has drawn up the technical documentation and affixed the relevant conformity marking (CE)
- Fulfilled its traceability obligations and accompanied, where relevant, the product by the instructions and safety information in a language easily understood by consumers and other end-users as determined in the IFU and labelling procedure in the MDR
- Indicate the necessary elements on the label and its visibility of safety information printed on the product or the accompanying documents
- Ensure while a product is under his responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in the applicable legislation
- Keep a copy of the EU DoC for 10 years or for the period specified in the relevant Union harmonisation act
- Ensure the technical documentation can be made available to the competent authority upon request
- Cooperate with the CA and upon request provide the necessary information and documentation
- The Importer must identify any economic operator who has supplied him and to whom he has supplied the product for a period of 10 years after the products has been supplied
- Sample testing of products placed in the market
The importing value of GrowthImports
GrowthImports is an independent MDR compliant importer providing hassle-free market access while maintaining flexibility, compliance and Increased quality standards. With over 30 years of combined experience, GrowthImports is dedicated to ensure the facilitation of a compliant and smooth international MDR/IVDR compliant importing process in the European market.
The independence provides flexibility in service, maintained control of the supply chain for manufacturers, reduced incompliance risks and cost effective importing. Channel conflicts can be avoided and distributors who have a wide range of products can focus on their sales and marketing efforts as described in this article.
Learn more about our services or contact us to discuss your specific importing situation.
These partners would also need applicable parts of a quality management system to ensure there is no jeopardy to the general safety or performance of the product.