Starting from 26th May 2021 medical device importers and distributors are required to comply with the Medical Device Regulation (EU) 2017/745 or EU MDR. This regulation replaced the previous Medical Device Directive (MDD).
The EU MDR regulation aims to have a robust, transparent, and sustainable regulatory set of obligations that can also be recognised internationally that can ensure clinical safety and fair access to the market for manufacturers.
Under this regulation, an importer is any natural or legal person established in the EU that places a device from a third country on the EU market. A distributor is defined as any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service.
Why are medical device importers and distributors affected by EU MDR?
Because the new MDR has a life-cycle approach to safety, the medical device industry under the EU MDR has a bigger evidence-generation burden to achieve compliance.
In addition, the scope of medical devices to follow these rules has increased as well as the transparency of medical devices information publication.
The new European Database for Medical Devices and In Vitro Diagnostic Medical Devices – also known as EUDAMED – has a key role in making data available and improving the quantity and quality of data.
The whole medical device supply chain traceability will be affected. The regulation introduced a new system of Unique Device Identifiers (UDIs) to improve the identification and traceability of devices.
The UDI allows all stakeholders, including importers and distributors, to access basic information on devices through the European Database on Medical Devices (EUDAMED).
How are the importers and distributors affected by EU MDR? In accordance with the EU MDR regulation, every medical device’s packaging has to be uniquely identified through a lot number or a serial number affixed on the labelling.
Therefore, distributors and importers must co-operate with manufacturers to achieve an appropriate level of traceability of devices. They have the obligation to keep the UDIs for Class III implantable devices, preferably by electronic means.
How can MDR EU software help importers and distributors achieve compliance?
The information in EUDAMED has to be uploaded by, and accessible to everyone including the general public. This database gives access to the regulatory documentation and is used by manufacturers to report incidents and exchange information.
Both medical device importers and distributors have these responsibilities:
Ensure the devices bear the CE marking, have the required information and label, and a UDI
Verify that devices are registered in EUDAMED
Stop devices that are not compliant to reach the market and inform the manufacturer and authorities
Report to authorities of any devices that have been falsified or are a serious risk to health
Include name, registered trade name or mark, place of business/importer and the address at which they can be contacted
Inform manufacturers and their authorised representatives in the event of complaints
Keep a register of complaints, non-conforming devices, recalls and withdrawals
Cooperate with authorities and share all the related documentation and information
An MDR EU software solution such as EudaMed Connect would allow importers and distributors to connect to EUDAMED system and share information of devices with the supply chain to meet regulatory requirements.
For more information about the obligations check the European Commission information.
How can Quick Pharm Solutions EudaMed Connect help your organisation?
We are experts in all the ins and outs of the EU MDR and can guide you through the system requirements so you can be fully compliant while making this process seamless and efficient.