The medical devices and in vitro diagnostics world has changed significantly under much tighter regulations. One standout example is the Medical Devices Regulation (MDR), which was adopted by the European Parliament and the Council in 2017. The Regulation states that medical devices can be placed on the EU market under CE certifications issued until 26 May 2024. Following the transition period, which has been extended due to COVID and other issues, products will require certification under the MDR.
In the past, unless a medical device was an implantable, regulatory requirements were quite straightforward. Now, companies must follow the same rigour that has long been required in the pharmaceutical industry.
To prepare for this tougher environment, companies must consider three priorities:
- Plan their regulatory strategy better, considering different scenarios in order not to waste money
- Invest more time and resources in the development and regulatory process well in advance, with the emphasis on regulatory due diligence
- Plan the conduct of full clinical investigations, which inevitably will push costs to new limits, and at the same time, prepare the practical future use of the product in the new healthcare environment, while also taking competitor products into account.
Some companies simply can’t afford to adopt these new steps, particularly those companies developing products for hospital use where the margins are already very tight.
In the past, the process was more simple. A medical device company made a product and received their CE mark, then sold their product to hospitals and other healthcare organisations.
New regulations will specially affect in Vitro Diagnostics and devices that enable the delivery of medicines or those devices that are composed of substances which may be systemically absorbed, among others. This will impact how the manufacturer manages day-to-day activities.
Battling discounts and competition
Increasingly, companies have to negotiate their contracts with the health authority payors, offering big discounts in order to remain competitive against manufacturers from parts of the world, such some Asian countries, which are better placed to offer keep costs low.
In this brave new world, preparation and regulatory strategy-making are very important, because a misstep or poor decision can have severe consequences. It is therefore imperative that companies find ways to reduce their risk.
Risk reduction is the new name of the game
Implementation of risk reduction policies begins with a proper regulatory plan that includes early interaction with the regulatory authorities. A clear understanding of the regulatory landscape in the major markets is key, since most authorities have tightened their expectations. Indeed, today the regulations in the EU and US are quite similar and there are no simple solutions.
Finding ways to limit risk
This is where having a good regulatory consulting partner can be invaluable, one who can advise on the likely risks and costs involved in bringing a product to the market. Ideally, companies should plan a global strategy, much as the pharmaceutical industry has done for many years, because it is no longer feasible or economically viable to produce medical devices for a single market.
The fallout from the breast implant scandal has had a profound impact on the industry. Today, companies must demonstrate that their product is not toxic, that it can cause no harm and it is a new product in an existing class or can demonstrate improvement over previous products. These changes have the potential to hinder innovation and discourage many smaller manufacturers from keeping their products on the market, particularly those with tight margins.
A global tightening of regulations
Regulatory complexity for manufacturers in unavoidable, regardless of whether you are dealing with the EU’s Medical Devices Regulation, the US FDA’s requirements for 510k premarket notification or premarket approval, or the increasingly rigorous requirements in markets that tend to follow either the EU or the US, such as Australia and Canada. Having a proper regulatory plan is now imperative.
“Risk reduction is the name of the game in this brave new medical device regulatory world. Preparation and regulatory strategy-making are crucial, because a misstep or poor decision can have severe consequences.”