The stated aim of the revised legislation is to ensure better consistency and safer products. Also it is to make certain that advancements in technological and scientific progress that have occurred since the medical device and IVD directives were implemented is legislated for, while maintaining fair and free trade of devices throughout the EU. Since 2012, the proposed text of the regulation has undergone rounds of negotiation and revision, with the latest amendments being made by the European Council in June 2015.
The next stage in the approval process is a “trilogue” negotiation between the European Parliament, Council and Commission, after which the final text will be adopted, possibly in Q1 or Q2 of 2016.
The proposed regulations, for the first time, provide definitions of an “importer” and a “distributor,” and outline new responsibilities for each. An importer is defined as “any natural or legal person established within the Union who places a device from a third country on the Union market,” while a distributor is defined as “any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market.”
The new regulations will require each party in the supply chain to confirm compliance of the device before making the device available on the market. Importers and distributors will have to verify that the device is CE marked and has a declaration of conformity, is accompanied by Instructions for Use, and has a Unique Device Identification (UDI).
Additionally, importers will have to verify that the device is labeled in accordance with the regulation, that their name and address appears on the device, the packaging or in an accompanying document. The importer will need to verify that the device is registered in the EU registration database and they will have to add their details to the registration. They must also verify that an EU Authorized Representative has been designated and that the device registration database includes details on the EU Authorized Representative. Importers must keep a copy of the device declaration of conformity and CE certificates (as applicable) on file for a period of at least 5 years after the device has been placed on the market, or 15 years for implantable devices.
Importers and distributors will be obliged to ensure that while the product is under their responsibility, it is stored and transported correctly. Product complaints, non-conformances and recalls must be logged. Complaints of suspected incidents must be forwarded immediately to the manufacturer for investigation. If an importer or distributor has reason to believe that a device is not in conformity with the regulation, presents a serious risk or is falsified, they will be obliged to inform the competent authority and cooperate with actions to eliminate risks. They will be obliged, upon request of a competent authority, to provide free samples of a suspect device or grant access to the device.
Distributors and importers must also co-operate with manufacturers to achieve an appropriate level of device traceability. Each party must be able to identify any economic operator to whom they have supplied a device; any economic operator who has supplied them with a device; and any health institution to which they have supplied a device. These records must be available to the competent authorities for a period of at least five years after the device has been placed on the market, and for a period of 15 years for implantable devices.
These new responsibilities for importers and distributors directly impact supply and distribution contracts. Importers and distributors need to ensure that their contracts with other parties in the supply chain include clauses that outline regulatory responsibilities. They will also need to update internal processes and procedures and ensure that they have suitably trained staff to perform the additional regulatory compliance responsibilities.
From a device manufacturer’s perspective, they should review and update their importers and distributors contracts to make certain that their supply chain partners have the capability to perform the functions assigned to them.Once the final text of the regulations is agreed and adopted by the European Parliament, It is likely that the medical device regulation will come in to force after three years. Due to the radical overhaul of the classification system for IVDs, a longer period of five years is proposed for the IVD regulation. When the regulation is written in to law, the requirements will apply to all medical devices, whether currently on the market or new to the EU market after this date.