Concerned about what the new EU MDR 2020 regulations mean to you? Volker Watzke, Domino Printing Sciences, offers advice on how to become compliant as quickly and efficiently as possible
The deadline for ensuring compliance with the European Union’s Medical Device Regulations (EU MDR) is looming. These new regulations are aimed at improving the traceability features and safety management of medical devices for sale within the EU. With less than nine months to go before the deadline, the countdown is on for medical device manufacturers to ensure they are compliant.
What is required from the EU MDR?
The EU MDR will come into force on 26 May 2020, replacing the EU’s current Medical Device Directive (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC). Manufacturers of medical devices for sale within the EU must adhere to strict guidelines to ensure their products are safe to use.
From 26 May 2020, all medical devices will need to be assigned a unique device identification (UDI) code. Devices which fall under Class III and Class IIa/b will need to have their UDI recorded, indexed, and registered on a central EU database called EUDAMED – the European Database for Medical Devices.
Manufacturers of Class III and Class IIa/b products will be responsible for sharing product data according to Annex VI Part B of the regulation. Manufacturers of Class I products will also be required to collect and save product data but need only share this information if requested.
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 Failure to comply with these procedures may mean that devices are withdrawn from sale, with device manufacturers no longer able to supply their products to other EU member states.
Where are we now?
The technical specification for EUDAMED is expected to be released by the end of 2019. 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.
Manufacturers will have approximately five to six months from the release of the technical specification of EUDAMED and the final date of registration. It is, therefore, advisable to begin collecting data as soon as possible. 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 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. Of the 57 notified bodies across Europe dealing with current legislation, only 38 have applied for accreditation to the EU MDR.
At the time of writing, only four notified bodies had achieved the new accreditation.
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.
