As well as preparing all data in advance of the May 2020 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 in 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.
Issuing agencies
In June 2019 GS1 became the first issuing agency for EU MDR compliant codes, meaning that 2D Data Matrix and GS1-128 codes can be used going forward. It is expected that other issuing agencies will follow suit, with potential for the use of HIBCC and ICCBBA coding in the future.
Notified bodies
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.
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.