How has the regulatory landscape changed in recent years?
As with many other industries, the red tape encircling the medical devices sector has become tighter in recent years. Medical devices must now be marked by Unique Device Identification (UDI) codes, which work in accordance to the EU MDR (Medical Devices Regulation), or to the FDA regulations (Food and Drug Association) if the products are manufactured for the US.
The differences set between the two regulatory bodies are demonstrated on the code types. The EU requires a “UDI-DI” (UDI-Device Identifier) code, or “UDI-PI” (UDI-Production Identifier) code, while the US only requires a “DI” (Device Identifier) code or a “PI” (Production Identifier) code. The terms UDI-DI and DI, themselves, reflect the static data and the GTIN (Global Trade Item Number) allocated by GS1, whereas UDI-PI and PI are the dynamic data, which includes an expiry date, manufacturing date, lot number, and serial numbers if required.
Different code details make it easy to identify medical device manufacturers as well as other important information, such as product dimensions and intended usage. It also makes it easy to recall potentially faulty products.
Why does the regulatory landscape change as time moves on?
Patient welfare is paramount. Product registration – in the EU at least – allows regulatory bodies to ringfence the market. They have more control and a better view of which products are sold in Europe and in what quantities, which helps to tackle the issue of counterfeit devices. The evolution of regulatory controls also facilitates efficient recall procedures if something goes wrong. Ultimately, enhanced regulation is always designed with patient welfare in mind.
Are there any drawbacks of regulation?
There’s no doubt that enhanced regulations help to protect patients, but there are drawbacks too. We can see this currently in Europe with the implementation of the EU Medical Device Regulation (EU MDR). Under the new rules, every manufacturer and every device must be audited and approved by a Notified Body. At the time of writing out of 57 Notified Bodies, only 38 have applied for new accreditation from the EU. Of those 38, only four (BSI, TÜV Süd, IQM, Dekra) have been granted accreditation, with more to follow.
This has created a huge backlog of manufacturers and devices that are waiting to be approved – some 2 million. This is putting huge pressure on manufacturers, suppliers, and start-ups who cannot get new or updated products to market because they have not been audited. This presents a very real threat to the financial wellbeing of many manufacturers, where the money invested in product development is not recovered quickly enough.
The regulatory landscape also risks starving the sector of innovation. Some manufacturers – many of whom are start-ups – are taking a look at the medical device sector and deciding that it’s not financially viable given the long waits to get to market. These risks are choking the supply of innovative new products to the sector, which could be to the detriment of health outcomes.
What changes lie ahead in the medical device landscape?
More countries to adopt medical device regulations
Many countries are poised to adopt medical device regulations of their own, including South Korea, India, Russia, Brazil, China, New Zealand, Canada, Colombia, Saudi Arabia, and Turkey. This presents a big opportunity for manufacturers who are well prepared to help the medical sector adjust.
Fewer counterfeit devices
Many countries simply don’t know how many medical devices are used in their medical sector. Germany, for example, puts the number somewhere between 800,000 and 1.5 million – that’s a huge range, and nobody knows if there’s even more out there. This opens the door for counterfeit criminals to enter the market, posing a huge risk to patient safety. The future is one where every product must be audited, approved, logged, and tracked – from production to patient. This dramatically reduces the risks posed by counterfeit drugs and devices.
Smarter supply chains
Unique product identifiers remove the risk of health professionals ordering the wrong product. Staff will know exactly what they are getting from which manufacturer, and the whereabouts of individual products can be tracked as they pass through the supply chain.
Smarter inventory management and procurement
With unique product identifiers, hospitals will have a tighter grasp on their inventory of stock and will be better able to manage procurement cycles. The coding and data management demands facilitate a clear overview of what stock is held, how quickly certain products are used and when replacements should be ordered.
More certainty for SMEs
Despite SMEs supplying 95% of market products, it’s likely that only large manufacturers, with a dedicated legislations team, have had the opportunity to get their view across when it comes to the EU MDR. It’s easier for large manufacturers to adjust to new regulations because they have more manpower, larger budgets, and more resources. Unfortunately, this has left SMEs struggling to adapt. In future, expect more collaboration between manufacturers, tech suppliers, and regulatory bodies to make it easier for SMEs to comply with regulatory changes.
The digitalisation of coding operations
GS1, the organisation responsible for developing global standards for business communications, is being used as the only issuing agency within the EU for now, bringing cohesion to healthcare systems across Europe. Its involvement in this sector has meant that products must now be associated with additional data and codes will vary on an item-level to selling unit basis. Dynamic coding, which allows for edits to be made to a code after the product has already come to market, is, therefore, necessary to bring full automation to a company’s coding operations. In some countries, Domino is a solution provider of GS1.
>> GS1 standards in the Pharma industry
How will changes benefit industry?
There’s little doubt that changes to any regulatory framework have the potential to cause big headaches for manufacturers and suppliers. Yet there are opportunities too: more trust in the sector, smarter supply chains, and more efficient procurement. And the biggest benefit of all? Enhanced patient safety and recall procedures
Confused? Let us help
We’re not just a manufacturer of the coding and marking technology that the medical device sector needs. We are the only one with a robust and complete understanding of the regulatory landscape. To the point where we are invited to speak at conferences about the challenges facing healthcare manufacturers and consult on the tech infrastructure manufacturers require to future-proof their operations. We can guide and advise you too – or even provide training if necessary. Get in touch and let’s start the discussion.