How has the regulatory landscape changed in recent years?
Similar to various other industries, the bureaucratic requirements surrounding the medical devices sector have become more stringent in recent years. Currently, medical devices must bear a Unique Device Identification (UDI) Code, aligning with either the EU MDR (Medical Devices Regulation) or the FDA regulations (Food and Drug Association) if intended for the US.
The distinctions between the two regulatory bodies are evident in the code types. The EU mandates a “UDI-DI” (UDI-Device Identifier) code and a “UDI-PI” (UDI-Production Identifier) code, while the US only necessitates a “DI” (Device Identifier) code and a “PI” (Production Identifier) code. The terms UDI-DI and DI denote static data and the GTIN (Global Trade Item Number) allocated by GS1, while UDI-PI and PI represent dynamic data, encompassing an expiry date, manufacturing date, lot number, and, if needed, serial numbers.
These divergent code details facilitate the identification of medical device manufacturers and provide crucial information such as product dimensions and intended usage. Additionally, they simplify the recall process for potentially defective products.
Why does the regulatory landscape change as time progresses?
Patient welfare remains paramount. Product registration, particularly in the EU, enables regulatory bodies to regulate the market effectively, gaining better insights into the products sold in Europe and their quantities. This aids in combating counterfeit devices. The evolution of regulatory controls also streamlines recall procedures in case of issues. Ultimately, enhanced regulation is always designed with patient welfare as the primary focus.
Are there any drawbacks to regulation?
While heightened regulations undeniably safeguard patients, there are drawbacks. A current example is seen in Europe with the implementation of the EU Medical Device Regulation (EU MDR). Under these new rules, every manufacturer and device must undergo auditing and approval by a Notified Body. As of now, out of 57 Notified Bodies, only 38 have sought new accreditation from the EU. Of these, only 13 (including BSI, TUV Sud, IQM, and Dekra) have received accreditation, with more to follow.
This backlog has left around 2 million manufacturers and devices awaiting approval, putting immense pressure on businesses, suppliers, and start-ups unable to bring new or updated products to market without undergoing audits. This poses a significant threat to the financial stability of many manufacturers, where the investment in product development may not be recovered quickly enough.
Moreover, the regulatory landscape risks stifling innovation in the sector. Some manufacturers, especially start-ups, may find the medical device sector financially unviable due to lengthy market entry waits. This threatens the supply of innovative products to the sector, potentially impacting health outcomes.
What changes lie ahead in the medical device landscape?
More countries adopting medical device regulations
Numerous countries are gearing up to implement their own medical device regulations, including South Korea, India, Russia, Brazil, China, New Zealand, Canada, Colombia, Saudi Arabia, and Turkey. This presents a significant opportunity for well-prepared manufacturers to assist the medical sector in adapting.
Reduction in counterfeit devices
Many countries lack precise data on the number of medical devices used in their medical sector, creating an opening for counterfeit criminals to enter the market, posing a considerable risk to patient safety. The future envisions every product undergoing auditing, approval, logging, and tracking, significantly reducing the risks associated with counterfeit drugs and devices.
Smarter supply chains
Unique product identifiers eliminate the risk of health professionals ordering incorrect products. Staff will have precise information on what they are receiving from which manufacturer, and the whereabouts of individual products can be tracked throughout the supply chain.
Enhanced inventory management and procurement
With unique product identifiers, hospitals can gain better control over their stock inventory, allowing for improved management of procurement cycles. Coding and data management requirements provide a clear overview of stocked items, consumption rates, and optimal timing for reordering.
Increased certainty for SMEs
Despite SMEs supplying 95% of market products, it is likely that only large manufacturers, with dedicated legislative teams, have had the opportunity to voice their opinions on the EU MDR. Large manufacturers, with more manpower, larger budgets, and more resources, find it easier to adapt to new regulations, leaving SMEs struggling to comply. In the future, expect more collaboration between manufacturers, tech suppliers, and regulatory bodies to ease compliance for SMEs.
Digitalization of coding operations
GS1, the organization responsible for global standards in business communications, is currently the sole issuing agency within the EU. Its involvement has brought coherence to healthcare systems across Europe. Products must now be associated with additional data, and codes will vary on an item-level to selling unit basis. Dynamic coding, allowing edits to codes after a product has come to market, becomes necessary to achieve full automation in a company’s coding operations. Domino serves as a solution provider of GS1 in some countries.
GS1 standards in the Pharma industry
How will changes benefit the industry?
Changes to any regulatory framework have the potential to create challenges for manufacturers and suppliers, but they also offer opportunities for increased trust in the sector, smarter supply chains, and more efficient procurement. The most significant benefit is the enhancement of patient safety and recall procedures.
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