Medical Device Regulation 2017/745 (MDR) – What does this mean for resellers of Medisol BV?
At Medisol we want it to be as easy as possible for you to be a reseller, even with the new MDR rules! Therefore as a supplier, we ensure the following:
- The CE marking and a Unique Identification Code (UDI code) are on the product.
- The EU declaration of conformity has been drawn up.
- The user instructions are available to download at cprmanual.com.
- The importer from where the product is sourced meets the requirements.
- We test whether products meet these requirements by test-sampling.
- Implementation of a system to register complaints.
- Passing details of all product complaints and reports to the manufacturer. This also applies to products which have been withdrawn from the market.
- Provide information to competent authorities if there is suspicion that a device does not meet all the requirements.
- Implementation of a quality management system.
- Ensuing traceability via the registration of Unique Identification Codes (UDI code), registration numbers (UDI-DI code) and lot numbers (UDI-PI code) upon receipt and delivery.
- Overview of transport and storage.
- Preparations for ISO certification (according to ISO 13485) for Medisol, scheduled to be completed by the end of July. Further evidence that we follow all applicable rules.
The reseller can choose between drop shipment and delivery to his own address. When the reseller chooses to have orders delivered to his own address, he must ensure that he complies with the MDR guidelines. In this case, the dealer must ensure to:
- Implement a complaint registration.
- Pass on complaints and reports about devices to the supplier. This also applies to products which have been withdrawn from the market.
- Implement a quality management system.
- Ensure traceability through the registration of Unique Identification Codes (UDI code), registration numbers (UDI-DI code) and lot numbers (UDI-PI code) upon receipt and delivery.
If the reseller chooses only to place drop shipment orders with the supplier, Medisol as your supplier takes care of the majority of the MDR compliance. In this case the reseller only needs to pass on complaints and reports concerning faulty devices to us as the supplier.
FAQ: Below we have collected some frequently asked questions and answers for clarification.
” Oh no! I have completely forgotten that the MDR rules will enter into force on May 26 - what do I do?”
There is no need to panic. As soon as you have signed the new reseller contract, Medisol ensures that you live up to all new requirements and restrictions. Be sure to contact us in the case of complaints regarding products. Keep all invoices so that you register which products are where. When using the Drop Shipment option, Medisol will also register this information.
”What is ISO 13485?”
An ISO certification is an international standard that proves that you work according to a quality-assured system that complies with current regulations. The ISO standard 13485 is the specific standard that concerns the production and distribution of medical products. Medisol is scheduled to be certified under ISO 13485 within the next few months.
” What does it mean for me to implement a complaint register?”
If you receive a complaint from a customer regarding a delivered product, please contact us at Medisol, and we will make sure to register your complaint in our system and of course do what we can to solve the issue. In this way your complaint is registered so you no longer have to consider it.
” I do not want to use Drop Shipment, does the dealer agreement still work for me?”
Yes, but this means you will have to spend more time linking the products to the customer (traceability). You can do this by saving all invoices where Medisol details any expiration dates, serial numbers and LOT numbers. By attaching the invoice to your own order registration, you can always find out which product is with which customer.
” I often hear that I should not buy an AED without FDA labeling. Is it true?”
No, that's not true. The CE marking is the European documentation that applies for medical products to be sold within Europe. The FDA is the US equivalent. For us, it is the European rules that are important. It is true, however, that the CE rules will be tightened, but all AED manufacturers that we work with have confirmed that they will live up to the new CE rules.
” I am happy with our current agreement and do not want to sign the new dealer contract. Will this mean I can no longer be a Medisol reseller?”
Unfortunately this is true. For us at Medisol, it is important that we follow all applicable rules and guidelines and our resellers are treated and protected in the best possible way. For this reason the new reseller contract is absolutely necessary because it supports you in connection with the new MDR rules. Remember that you are always welcome to contact us if you have any questions or doubts about the contract and we will be happy to talk it through with you.
Last but not least, the MDR legislation comes into force on 26 May 2021, but remember that there is a transition phase of another two years so you do not have to panic. At Medisol, we will be ready on May 26th.
You are always welcome to contact us if you have any questions. We are ready here to help you further in the best possible way.