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Sarah Lepak BHTAAs the EU looks set to delay the Medical Device Regulation (MDR) deadline by one year, many manufacturers and suppliers in the industry will breathe some small sigh of relief as they continue to work to meet the comprehensive new rules.

Importantly, however, this postponement will also prove valuable for many mobility retailers unaware that MDR may have a substantial direct impact on their business as well.

To learn just what effect the new and widespread regulatory changes will have on mobility retailers, Sarah Lepak, Director of Governance & Policy of the British Healthcare Trades Association (BHTA), shared her insights to help retailers prepare.

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By Sarah Lepak, BHTA Director of Governance & Policy

From May 2020 the Medical Device Regulation (MDR) is scheduled to come fully into force and all organisations selling and supplying medical devices need to be aware of the requirements placed on everyone in the supply chain to the end-user.

Under the MDR, if you are not a manufacturer and not an importer, then you are, by default, a “distributor”.  This, therefore, encompasses retailers, dispensing appliance contractors, charities, and even hospitals.

The definition of a ‘distributor’ is set out in Article 2 (34) and the obligations on distributors are set out in Article 14.  These obligations are paraphrased below:

Distributors must verify:

(a) that the device has been CE marked and that the EU declaration of conformity of the device has been drawn up

(b) the device is accompanied by the information to be supplied by the manufacturer (label, instructions for use, warnings, whether it is sterile…) as per Article 10(11), Annex I Section 23

(c) for imported devices, the importer has complied with the requirements set out in Article 13(3) (i.e. has their name, registered address and contact address on the device or its packaging, without obscuring the manufacturer’s information)

(d) that, where applicable, a UDI has been assigned by the manufacturer (a UDI is a unique device identification number, either on the device or its packaging, and for most devices in our sector this is usually in the form of a human-readable bar code)

You can use a sampling method for (a), (b), and (d) above.  You must not supply a device to a user if you do not believe it meets one or more of the above and if so, must inform the manufacturer; and must not supply it until the matter has been corrected.

You must meet the conditions set by the manufacturer (if any) for storage or transport of the device whilst it is under your responsibility.

If you consider it presents a serious risk or is a falsified device (i.e. incorrectly CE marked), you must also inform the competent authority (which in the UK is the MHRA).  In the case of serious risk, this must be reported immediately.

You must cooperate with the manufacturer to ensure that necessary corrective action is taken to bring the device into conformity, to withdraw it or recall it, as appropriate.

Where you have received complaints or reports from customers, healthcare professionals, or patients about suspected incidents related to a device you must immediately forward the information to the manufacturer. You must keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer informed, providing them with any information they ask for.

(If the device is imported, then the manufacturer’s authorised representative and the importer should also be informed wherever it says above to inform the manufacturer.)

You must provide the competent authority (MHRA), on request, with all the information and documentation at your disposal related to a device (as per (a) to (d) above).  You must also co-operate with the competent authority (MHRA), at their request, on any action taken to eliminate the risks posed by devices you supply and, if requested, provide free samples of the device.

You must keep records for 10 years to identify manufacturers or importers who have supplied you with a device, and any health institution or healthcare professional to whom you have supplied a device (Article 25, Article 10(8).

What does this mean in practice?

You should put a sampling process in place and make sure that manufacturers are providing everything you need to meet your obligations. They should make clear which of the products they sell to you are medical devices. We anticipate that responsible manufacturers will update their terms and conditions of business to reflect the obligations you have as a distributor.

You need to ensure you set up and maintain the log described regarding complaints, recalls etc.

You should capture the device UDI as a data field in your records for track and trace purposes and for reporting of incidents.

You must co-operate with any recalls or corrective action and we suggest that if you become aware of an incident where a device posed a serious risk to a customer you should attempt to quarantine the item.

You need to check that your insurance reflects the fact that you supply medical devices and that you have adequate liability cover in place.

The full text of the MDR can be found here

You can report a medical device incident here

Please note that this MDR article is an interpretation only and does not constitute legal advice.  The MHRA is drafting guidance for distributors and the BHTA will alert its members as soon as it is available.

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