There are two type of organizations in the EU that remanufacture single use medical devices (SUD) manufactured by ‘original equipment manufacturers’ (OEM):
1) Hospitals and other healthcare providers called: reprocessors
2) Commercial re-processors now called: remanufacturers.
Not all EU countries allow ‘remanufacturing’ and up to now remanufactured devices did not fall under the Medical Device Directive 93/42/EEC but they will fall under the new Medical Device Regulation (MDR) to be published March 2017.
There are two countries, that we are aware of, that officially allow remanufacturing of single use medical devices:
1) Germany. has its own regulations up to now; and
2) UK, who published a new guidance document in June of 2016.
France does not officially allow remanufacturing and the rest of the EU countries do not have formal policies, but they are aware that remanufacturing is taking place in their countries.
The EU Parliament/ EU Commission decided to deal with this division among EU Member States with the following solutions in the MDR:
a) EU countries have to decide if they legally allow remanufactured devices in their market or not;
b) Hospitals and other healthcare providers will need to meet minimum requirements that hopefully will be more specifically outlined in the new regulation when it is published and many hospitals already fear they will be unable to meet these. Their activities are usually referred to as ‘reprocessing’ and the single use devices must be used in the same hospital, they may not be commercially placed on the market; and
c) Commercial remanufacturers will need to meet the same MDR requirements as the original manufacturer (OEM) including Notified Body certification before they can apply the CE mark. They must place their own name and trademarks etc. on the remanufactured single use devices. This is a whole new group of clients for Notified Bodies whose resources to service their existing clients are already stressed.
This all seems very similar to other country’s regulations including US-FDA, Australia etc.
It is the specific guidance documents that are cause for concern. Let’s use the UK MHRA document as an example, you can find the: Single-use medical devices: UK Guidance on remanufacturing of June 2016, right here:
There are a few sentences in this MHRA document we would like to draw your attention to:
Page 4 of 11: Note: all class I medical devices are excluded from this policy. The MHRA considers that Class I products should not be remanufactured as there would be no external or independent assessment of CE mark Compliance.
Page 6 of 11: To maintain traceability of the original manufacturer’s device and as part of the risk mitigation the remanufacturer should consider the need for the inclusion, on the device label and packaging, the original manufacturer’s identifiers, specifically the company name, full address and serial number or unique identifier.
The MHRA has responsibility for ensuring safe products in the UK. We have not considered the intellectual property of the Original Equipment Manufacturer (OEM) or their permission for their name/product being used.
Page 7 of 11: If during remanufacturing of the device a problem is identified and it:
1) concerns the Original Equipment Manufacturer’s design and
2) affects the safety of the original device, the remanufacturer should inform the Original Manufacturer of the issue.
We strongly recommend that you, the Original Equipment Manufacturer, read this 11 page UK document in its entirety and discusses with your legal advisors how to protect your intellectual property in the EU. We all need to keep track of any additional remanufacturing of single use devices guidance documents that may be issued on a country-by-country basis in the future.