For many years, medical devices played second fiddle to medicines in the pharmaceutical industry. Their role was to facilitate the use of the “star” products, the drugs. However, the sector’s low profile became increasingly problematic. There was often confusion about the vast range of products falling under the medical devices umbrella, and, perhaps more importantly, there was clearly a need for tighter oversight when it came to safety compliance.
Consider the fact that a simple band-aid, electronic thermometers, and diagnostics software all fell under the classification of medical devices and it’s clear that a one-size-fits-all regulation doesn’t work for such a diversity of products. In response to this challenge, medical devices were divided into classes, predominantly based on their risk: class I, Is, Im, IIa, IIb and III. However, as technology advanced, so too did medical devices, resulting in active devices, software, in vitro diagnostics, self-diagnostics, etc., and once again adding to confusion as to how these should be managed and regulated.
While the need for a tougher regulation was well-understood (and underway), it took a worldwide catastrophe like the COVID-19 pandemic to highlight the risks of an “easy” and confusing regulation for medical devices in the European Union (EU). Nowhere was this more apparent than with surgical masks, a class I medical device.
EU Market Context
In response to the misalignment between rapidly evolving medical device technologies and the EU’s Medical Device Directive 93/42/CEE (MDD) a new EU Medical Devices Regulation (MDR – Regulation EU 2017/745) was approved in May 2017, and the industry was preparing to implement it by May 2020. But then COVID-19 arrived in Europe in February 2020, changing our lives and plans and, as the virus spread through the EU, implementation plans were put on hold.
The MDR will now come in force on 26 May 2021, according to the provisions of articles reported on Regulation (EU) 2020/561 of The European Parliament & of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions.
As we prepare for this important new regulation, it’s important to understand why it is so important.
Directive vs Regulation
The first aspect to consider is the regulation discrepancies across countries on how European legislation is structured. In the EU there are different kinds of legal acts, such as EU treaties, regulations, directives, decisions, recommendations, opinions, delegated and implementing acts.
The two legal acts that directly impact medical devices are:
A – EU Regulations: “… legal acts that apply automatically and uniformly to all EU countries as soon as they enter into force, without needing to be transposed into national law. They are binding in their entirety on all EU countries.”
B – EU Directives: “…require EU countries to achieve a certain result, but leave them free to choose how to do so. EU countries must adopt measures to incorporate them into national law (transpose) to achieve the objectives set by the directive. National authorities must communicate these measures to the European Commission. Transposition into national law must take place by the deadline set when the directive is adopted…”
What this means is that with a directive, such as Medical Device Directive 93/42/CEE, each country can interpret and apply it locally, creating regulatory differences and market gaps between countries. Each country will also issue local decrees on the applicability of the directive.
On the other hand, when a regulation enters in force, each country must apply it in full, without any local exceptions.
CoViD-19: The perfect storm
When COVID-19 started spreading across Europe and all countries realised the urgent demand for medical devices and personal protection equipment, the EU regulators quickly formed temporary regulations to make it possible to import these from foreign countries, contrary to the normal process. The decision was understandable. The demand was so great that doctors and nurses were caring for patients using plastic bags and fabric masks for protection.
Meanwhile in China, the world’s largest manufacturer of medical devices began full production again after a two-month lockdown, just as lockdowns started in every European country. It was the perfect supplier for Europe just as internal production shutdown.
In addition, there were other challenges that Europe was facing, such as forgery of CE compliance certificates and counterfeit medical devices (masks, individual protection devices, hydroalcoholic gel). COVID-19 test kits also became a serious issue when it came to reliability. This is a critical consideration given that the difference between a negative and a positive result could impact hundreds or even thousands of lives. Before COVID-19, we might never realised that the sensitivity of a medical device diagnostics kit could put so much at stake.
To respond to the dramatic increase in requests for COVID-19 first aid medical devices, The European Commission has temporarily allowed the marketing of non-CE marked products in some categories, such as personal respiratory protective equipment, under Recommendation (EU) 2020/403. The marketing of these devices is permitted if a number of criteria are met, but this only applies to equipment intended to protect healthcare professionals from the coronavirus SARS-CoV-2.
Moreover, to increase production capacity of protection devices and disinfectants, on 20 March 2020, the European Commission and the European Standardisation Organisations agreed that all the relevant European harmonised standards would exceptionally be made freely and fully available for all interested companies. This action allowed manufacturers to place on the market high-quality devices to protect patients, healthcare professionals, and citizens in general, including:
• medical facemasks
• protective clothing
• surgical drapes
• disinfectant and sterilisation agents
• personal eye protection
• medical gloves
• respiratory protective devices
Under the same considerations, the US Food and Drug Administration (FDA) extended the scope of the EUA “Emergency Use Authorization ” to medical devices and in vitro diagnostic applications.
“On the basis of this determination, the Secretary of HHS has subsequently declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 (February 4, 2020), personal respiratory protective devices (March 2, 2020), and other medical devices, including alternative products used as medical devices (March 24, 2020), for use during the COVID-19 outbreak pursuant to section 564 of the Act and subject to the terms of any authorization issued under that section….” ( Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020).
In the EU, the Notified Bodies have also been encouraged to speed up evaluations of urgently required medical devices, such as ventilators, oxygen chambers, and surgical masks.
In response, new players have entered the market, such as automobile manufacturers, which have leveraged their expertise in designing engines and vehicles to start producing medical devices. This is reminiscent of World War II, which is the last time multiple industries responded to an urgent global need.
Now, one year on from the start of the pandemic, EU regulators must urgently apply the new MDR to fix the gaps and prevent future exposure. What will happen to the “Emergency Use” approvals and new players on the market? Are they prepared to meet a regulation that medical device manufactures have been preparing for since 2017? We will be watching carefully to find out what unfolds in the months ahead.
One thing we’ve learned with the pandemic: you can never be overprepared.
Preparing for the future
In recognition of the challenges faced, ProductLife Group has established the PLG MedTech Centre of Competencies to help companies in areas ranging from clinical evidence, to post-market surveillance, to quality management and risk management, to finding and working with a Notified Body.
The team is led by Paolo Guerra, an expert in the medical devices industry across quality, manufacturing, risk management, and project development of all classes of medical devices, including digital apps and SaMD.
As the date of MDR implementation draws closer and as its implications become clearer for the industry, PLG will continue to expand its team of experts to support customers in a flexible, customised, yet cost-efficient way.
Find out how we can support you on your MDR journey.