New medical device regulations. Time is running out for distributors
Wednesday 29th May 2019
JR Biomedical Ltd.
The new European Regulation on IVD's (diagnostic tests) EU-MDR/2017/746 came into force 25th May 2017 with a 5 year transition period. This means that all laboratory and self test diagnostic tests sold in the UK will have to be compliant with these regulations by May 2022. These new obligations may impact current supply and distribution agreements.
An important point related to the distribution chain for medical device manufacturers means that each economic operator (manufacturer, importer, and distributor) must verify that a previous economic operator has complied with the EU MDR requirements. Thus, importers and distributors must ensure independently that, prior to placing a medical device on the market, the manufacturer, importer and the device itself meet the stipulated EU MDR regulatory requirements.
Distributors must verify that all of the following requirements are met:
- the device has been CE marked and that the EU declaration of conformity of the device has been drawn up
- the device is accompanied by the information (on the packaging and IFU) to be supplied by the manufacturer in legible and easily understandable English
- for imported devices, the importer has complied with the requirements and included the importer's contact details
So, an important question to consider when purchasing diagnostic tests is does your distributor have a Quality Management System (QMS)? Does this include procedures for traceability, and recall in the event that this should become necessary? Do they keep a register of complaints, non-conforming devices, recalls and withdrawals? Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available must immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative (for devices manufactured outside the EU) and the importer.
Forward traceability of a medical device throughout the distribution chain is another crucial feature of the EU MDR as all economic operators will have to track devices. Manufacturers, importers and distributors will have to identify at any given time from whom - and to whom - the medical device was supplied along the supply chain, including devices provided to health institutions and/or healthcare professionals.
Eventually all devices will have to carry a UDI (Unique Device Identifier) assigned by the manufacturer. This information will be registered in EUDAMED, a publicly accessible database currently being set up. Is your distributor aware of their obligation to register with EUDAMED once this database is up and running? And are they aware of the obligation to engage in post market surveillance activities and report complaints to the manufacturer? Can you also be confident that products you buy are stored appropriately in a clean environment before dispatch?
ISO 13485:2016 certificated by a UKAS accredited certification body is the "gold standard" QMS that ensures compliance with the regulatory requirements for medical devices. ISO 9001:2015 certification, while demonstrating that a supplier has quality systems and procedures in place, does not ensure compliance with these regulatory requirements. Investment in certification is expensive and time consuming and while not currently mandatory for distributors, an organisation that has been successfully audited to ISO 13485:2016 has shown that they have a robust QMS that does comply with all these requirements. Annual re audits are required to maintain certification giving you confidence that a distributor holding ISO 13485:2016 will supply you with products that consistently meet regulatory and quality requirements.
For further information please contact our Quality Assurance and Regulatory Compliance Manager.