The Council of the European Union has announced and endorsed new measures to eliminate medical device shortages. The council says these new measures will also allow for better access to information regarding the same and create greater transparency for everyone in the industry.
Background
The In Vitro Diagnostic Medical Device Regulation (IVDR) was developed in 2017 but became applicable in 2022. Member states adopted it alongside the Medical Device Regulation (MDR), which became applicable a year prior. These regulations were aimed at modernising rules surrounding medical devices, including In-vitro Diagnostics (IVDs), and improving patient safety.
The changes to the IVDR are so far-reaching that many IVDs currently being sold in the EU market have yet to comply with the regulations. Manufacturers based outside the European Union also have to comply, and they can work with a European authorised representative for medical devices to ensure this.
The Need for New Regulations
The European Union started looking into ways to modernise current rules surrounding medical devices around 2017. The need arose out of scandals surrounding faulty silicone breast implants and metal-on-metal artificial hips.
The European Union realises that In-vitro Diagnostics and other medical devices are becoming more innovative and sophisticated. The rules established in the 1990s have not kept up with the latest technical and scientific developments in healthcare.
These older rules did not make it clear who manufactured specific products, and there were bigger concerns surrounding their safety due to a lack of clinical evidence and a shortage of information.
Even though member states had set up ways to control the market, these systems did not work well together and made sharing information and tracing products difficult.
The New Changes
The new regulations amend the legislation surrounding medical devices. They extend the transition period for specific IVDs with an added focus on high-risk diagnostics, including blood tests.
They also support the introduction of the electronic European database on medical devices (EUDAMED), a new database that is meant to be used by all medical manufacturers and players in the industry.
The regulations also provide mechanisms that manufacturers can use to prevent shortages of IVDs and other critical medical devices. The regulations also mandate manufacturers to flag any potential shortages of these critical medical devices and diagnostics.
Guaranteeing the Supply of Critical In-vitro Diagnostics
The Council says that about two-thirds of clinical decisions depend on information provided by IVDs, including tests for COVID-19, pregnancy, cancer, and HIV. The Council introduced new rules in 2017 to update and modernise the EU framework governing these products.
Because these rules are far-reaching and require additional regulations, technical and scientific expertise and capacity, many IVDs have not yet complied with the rules. This means they are likely to be eliminated from the EU market once this transition period passes if they are not compliant by them.
Extending the compliance deadline with manufacturers required to follow strict conditions will avoid a shortage of critical IVDs. The Council hopes this will happen without putting patients’ lives at risk.
The Roll Out of EUDAMED
The rules adopted by the Council of the European Union in 2017 provide a framework for the development and launch of a European database on medical devices. The council is doing this to ensure easy access to information and improve transparency because the database would contain detailed information on all medical devices sold in the European Union.
Initially, the Council asked manufacturers to wait until all six elements were ready. Three of the six elements are complete, two more will likely become available in 2024, and the last will likely be finished in 2027.
The European Union does not want to wait this long, so it is asking manufacturers to start providing information about their medical devices as soon as possible using the completed modules.
Flagging Potential Shortages
The European Union knows that catching any issues early is the best way to prevent shortages. The new measures require that manufacturers provide prior notice if they forecast an interruption in the supply of specific critical medical products and devices. They should provide such notice to all relevant authorities, healthcare professionals, health institutions, and economic suppliers they work with or supply to.
What Happens Now?
The European Parliament and the Council of the European Union Will formally adopt these new rules, regulations, and agreements once they undergo one or more stages of legal-linguistic revisions.
Anyone in the medical field in the EU should read and understand the new rules. The Council says this is the best way to ensure compliance and that they are not surprised when the new measures come into effect.
The Council of The European Union wants to keep patients safe and eliminate medical device shortages. It is doing this by implementing new measures to address both, with these regulations dictating the formation of a new database to track manufacturers, measures for announcing potential device shortages, and guarantees for the supply of crucial medical devices.