Mark Wasmuth, chief executive of the GMDN Agency – a non-profit organisation responsible for the ongoing maintenance of the Global Medical Device Nomenclature (GMDN) used to identify medical devices – explains why the new regulation should be viewed as an opportunity rather than a threat
With the EU’s new Medical Device Regulations (MDR) coming into effect in May 2020 and its potential to stimulate competition in the sector, the pressure is on manufacturers everywhere to ensure they are ready.
There have been growing calls for tighter licensing regulations to be applied to medical devices since the PIP breast implants scandal erupted in France in 2009. The current licensing system has grown outdated, exposing gaps in the regulatory system that have led to patients being treated with faulty products that have become too readily available in the market.
Concerns have also been raised about the varying standards of scrutiny provided by Notified Bodies within member states with some jurisdictions failing to store sufficient information on a device’s effectiveness or safety.
The new rules, which follow the lead of the US, will impose more stringent regulatory requirements on the registration of medical devices. By introducing uniform control of all Notified Bodies, the EU hopes to create a business environment where information can be seamlessly shared across borders.
With 123 Articles and 17 Annexes, the Medical Device Regulations are four times longer than its predecessor, the Medical Device Directive (MDD).
The MDR will force manufacturers to use clinical data already stored on multiple databases to a greater effect. As well as improving governance standards, it will provide the basis for enhanced legal clarity in post-market safety.
Hospitals will benefit from a transparent supply chain, where clear explanations of the product and its effectivity will be made available before they are obliged to buy. Not only will this apply to new products coming to market, but continuously for all products currently available to purchase.
It will take time to digest and, for some, the breadth of clinical data required by the EU will come as a complete shock.
Some of the most significant regulatory changes affect clinical evaluation for devices. Perhaps the most fundamental of these changes is the inclusion of a definition for the term itself – something not provided in the MDD.
According to the MDR, a clinical evaluation is a ‘systematic and planned process to continuously generate, collect, analyse, and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits of the device when used as intended by the manufacturer’.
The onus is on manufacturers to collate potentially thousands of pieces of data to clinically evaluate their devices. It is a monumental task, particularly as many manufacturers do not have the data required stored on a central database.
Recent research by the KPMG and Regulatory Affairs Professional Society found that 41 per cent of the 200 medical device companies surveyed were yet to evaluate the long term maintenance needed to comply with the looming regulation. More strikingly, of those surveyed 58 per cent had no strategy in place for remedying gaps in their clinical data or data collection processes.
If manufacturers are to be compliant in 2020, they must start investing now in the people and systems needed to be able to collate the data required.
The biggest challenge will be sourcing the data and ensuring that it is brought together in a compliant fashion and then submitting it in time. If the data has been properly assembled manufacturers should be able to submit in bulk with ease. Problems will arise, however, if there are gaps in the data and that could mean someone having to key in data product by product.
Companies should already have an MDR compliance cross-functional team in place. This is responsible for reviewing and discussing the regulatory impact on each department, it should also stratify regulatory requirements across each functional area, ranging from regulatory affairs to supply chain, and IT. It also needs a budget in place for the many additional costs that will be involved.
Evidence of any reviews alongside details of organisational changes – including the appointment and training of a person responsible for regulatory compliance (PRRC) – should be kept in order to satisfy the regulator that companies have adequately prepared. As part of this, make sure meetings regarding MDR compliance are minuted.
The EU hopes to stimulate competition in medical device market by giving hospitals the information they need to make informed choices about the clinical effectiveness of the products they buy. While the initial cost of accumulating the data may be burdensome to manufacturers, it marks a shift in power between hospital buyers and their suppliers.
For the first time, buyers will be able to scan a catalogue of devices available from a multitude of suppliers and choose the one that is right for them at a price that suits. Furthermore, they will be able to do so safe in the knowledge that the manufacturer has submitted all the prerequisite data it needs to gain regulatory approval.
The hope is that by forcing manufacturers to be transparent about their products and their ongoing effectivity, new players will be encouraged to enter the sector to fill supply gaps and improve product value.
Certainly, the MDR will work to make manufacturer’s products more visible to all in the market – competitors as well as buyers. For some it will be a threat while others will view it as an opportunity for growth.
What is clear is that there are currently too many companies chasing too few orders, and with market disruption anticipated from new players, in the end will be those manufacturers that offer true value that win out.
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