In April 2020, when the European Parliament voted to delay the implementation of the EU’s Medical Device Regulation by a year, some medical device manufacturers may have breathed a sigh of relief.
The delay was introduced in the hopes of allowing manufacturers more time to address the effects of the COVID-19 pandemic, though questions about whether device companies and notified bodies could have made the initial deadline have lingered since at least last year.
Now, the EU MDR has made its way back to the forefront of public discussion, as the European Commission has vowed to deploy the first of six sub modules of the EUDAMED medical device database by the start of December – enabling manufacturers to acquire a single registration number (SRN) which is needed to create device certificates.
With the new go-live date on the horizon, and the deadline for EU MDR compliance fast approaching, Volker Watzke, EU Medical Device Sector Manager at Domino Printing Sciences plc, offers medical device manufacturers advice on how to make use of the time remaining.
Recap: What is required from the EU MDR?
From 26th May 2021, the EU MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC).
As part of the new regulations, manufacturers of medical devices for sale within the EU must adhere to strict guidelines to ensure their products are safe to use. The regulations cover all medical devices sold in the EU – everything from scalpels and needles to pacemakers, prosthetic limbs, and medical devices with a cosmetic purpose such as coloured contact lenses.
By the time EUDAMED, the central European Database for Medical Devices, is fully functional all medical devices will need to be assigned a unique device identification (UDI) code, and have their UDI recorded, indexed, and registered.
The introduction of the EU MDR obligates medical device manufacturers to invest in technology to enable the fast and accurate application of traceability coding to products and packaging at the individual item level.
Failure to comply with these procedures may mean that devices are withdrawn from sale, with device manufacturers no longer being able to supply their products to other EU member states.
The European Commission delayed the introduction of EUDAMED by two years last October amid concerns that the IT system developed by the European Commission to implement regulations on medical devices would not be ready in time for the original May 2020 target.
However, despite subsequent delays to the compliance date for the EU MDR, the European Commission has now vowed to deploy the first of the EUDAMED medical device database by the start of December. This is in order to improve transparency and coordination of information regarding medical devices available on the EU market.
The Medical Device Coordination Group (MDCG) confirmed the European Commission is ready to move ahead with the EUDAMED actor registration module, a structure of six interconnected subcategories, ahead of its earlier March 2021 deadline. With the go-live date now on the horizon, MDCG is strongly encouraging manufacturers and other organisations to use the module to obtain a Single Registration Number (SRN).
With almost 18 months between the introduction of the first module and the full EUDAMED launch, organisations now have more time to get the SRN they need to use other features of the database. At one point, before the delays to EUDAMED and the MDR, member states faced the prospect of trying to validate all registration applications in just two months.
Where are we now?
With the EU MDR timeline apt to change, it is important that organisations stay abreast of current developments as and when they arise. Medical device manufacturers should speak to institutions such as GS1, as well as notified bodies and trusted partners for advice and support.
So far, manufacturers have the benefit of a technical bulletin, available from the European Commission, which provides information on how data should be submitted. The technical bulletin is addressed to the different needs of each manufacturer.
As EUDAMED displays a challenging and continuous project for each manufacturer, it is advisable to begin collecting data as soon as possible. Moreover, manufacturers should make themselves familiar with the technical aspects of gathering and uploading their data to EUDAMED. Manufacturers will need to collect data on each product according to the Annex VI, Part B of the EU MDR, and begin preparing the data for sharing on EUDAMED.
As well as preparing all data in advance of the revised deadline, manufacturers should ensure that they have the right partners who support them through the process. To ensure that their devices comply with the new regulations, manufacturers should speak to their code issuing agency and notified bodies for advice.
At present, some large medical device manufacturers are utilising up to 25% of their employee base for bringing their procedures up to standard. Small- and medium-sized manufacturers are unlikely to have the capacity to dedicate so much of their workforce and should consider options for external support.
In June 2019, GS1 became the first issuing agency for EU MDR compliant codes, meaning that 2D DataMatrix and GS1-128 codes can be used going forward. Further issuing agencies followed suit after, with potential for the use of HIBCC, ICCBBA, and IFA coding.
As part of existing EU Directives (90/385/EWG) and (93/42/EWG) manufacturers audit and check their products on a regular basis to ensure compliance. Notified bodies support manufacturers in this process to ensure that new and existing products can be sold. Of the 57 notified bodies across Europe dealing with current legislation, only 37 have applied for accreditation to the EU MDR.
At the time of writing, 17 notified bodies had achieved the new designation.
Manufacturers can decide which notified body they choose for their products but should bear in mind that some existing notified bodies will no longer be available for assistance under the EU MDR. The new process of designation is significantly more challenging, and as such, around 20 notified bodies have not applied.
The sudden lack of notified bodies has become a bottleneck for manufacturers seeking certification of their products and can be seen as a roadblock for innovation, as start-ups struggle to find support. Start-ups looking to register their products should speak to one of the 17 newly designated notified bodies for advice.
A global effect
The EU MDR covers all items sold within the EU, but this does not mean that only EU member states need to fulfil the requirements. All manufacturers that wish to sell their product in the EU need to ensure that they satisfy the EU MDR requirements, or they may see their products removed from sale.
Equally, manufacturers who are registered according to the EU MDR should focus future attentions on ensuring compliance in different parts of the world where additional legislation may be a factor. At present, the US, China, India, and South Korea are in the process of passing legislation on the identification of medical devices and drugs, with further discussions currently in progress in Australia, Brazil, Canada, Colombia, Japan, New Zealand, Russia, Saudi Arabia, Singapore, and Turkey.
Who can offer further advice and support?
With the deadline for ensuring compliance with the EU MDR fast approaching, the time to act is now.
The experts at Domino are on hand to help you ensure that your products are compliant with the upcoming EU MDR. At Domino, we provide validation packages to help manufacturers authenticate their products and prepare for EU MDR accreditation.
Our range of coding and marking solutions offers manufacturers of medical devices the most suitable technology in order to achieve UDI compliance. For advice and support in how to ensure your coding is EU MDR compliant, contact the experts at Domino.
For further insight into the upcoming EU MDR, listen to Domino’s latest podcast https://go.domino-printing.com/medicaldevicespodcast