Column | The MDR and Alternatives for MedTech
The regulatory environment for medical technology in Europe has entered a new era. A Europe-wide medical device regulation has come into force, which offers both challenges and opportunities for the players in the industry.
That was a long time coming. The Medical Devices Ordinance (2017/745) (MDR) introduced in April 2017 came into force on May 26 of this year. The MDR defines the “rules for the placing on the market, making available on the market or putting into operation of medical devices for human use and accessories for such devices” in the EU. The In Vitro Diagnostic Medical Devices Ordinance (2017/746) (IVDR) should follow in May next year.
Some may see increased regulation as a business challenge, but I believe it is indeed an opportunity. In more than 25 years of work in the field of artificial intelligence, I have come to appreciate the importance of an ethical and rights-based approach in the development and use of new technologies. I have done a lot of research on the ethics of technology, helping to research and define ethical guidelines and guidelines for AI ethics for the European Commission and other groups. I am firmly convinced that the MDR and IVDR have strict requirements and expectations of medical devices, but that they are essential for the acceptance and sustainability of such advanced technologies. All EU regulations start with protecting the fundamental rights of the individual citizen, but ultimately they will protect businesses too. Consumers expect technology to be trustworthy. We sincerely welcome guidance on the trustworthiness requirements. It’s about building an ecosystem of trust.
Benefits for MedTech companies
Whenever new regulations are introduced, companies will have questions and concerns about maintaining autonomy and the ability to innovate. However, the MDR and IVDR can serve as guard rails for companies and even as producers of new intellectual property. Below are some of the positive impacts and opportunities I see for medical device companies:
Clarity. MDR and IVDR create structures and cultures that increase safety and reliability for patients. The advantage for the industry is that it gains clarity about regulatory expectations and standards. Companies have a clear understanding of what the regulatory expectations and duties are, which regulators are involved and how they deal with them.
Consumer confidence. Today’s consumers expect regulation and oversight for most of the technologies, including medical devices, that are used for their health. They also understand the importance of their personal information – and the vulnerabilities. Compliance with regulatory standards gives the technology the independent trustworthiness expected by the market.
Risk reduction. Working in an unregulated area can create an unacceptable level of uncertainty and risk. Standing on the wrong side of public opinion can be disastrous for a company, especially at a time when social media and public discourse are dominating. The MDR and IVDR regulations ensure that companies have a line in the sand and know exactly where that line is.
Business development. In some areas, the MDR and IVDR can even trigger innovations. For example, regulatory compliance may require some companies to establish new audit protocols and methods. You then have a commercial opportunity to create new lines of business around these advances.
As technology and related ethics become more complex, regulation plays a key role. The alternative – a weak or regulatory vacuum – leaves companies vulnerable. The cons far outweigh the cost of compliance.
The European rules are broad and specific, but the considerations that are taken into account in shaping them are also very extensive and industry leaders play a role. Medtech companies concerned about the regulatory future of their industry in Europe have many options to make their voice heard. The design of European regulations is a transparent process – the doors of politics in Brussels are open to all those affected by the regulations. There are open consultation and feedback processes. Every company that wants to act on the European market is cordially invited to take part and contribute its perspectives. In fact, they are encouraged to do so.
Participation in the European regulatory process can also have wider implications. In recent years we have seen that many EU regulations are often in line with other international directives and standards and have played a pioneering role in many cases. In the USA, for example, many countries have adopted additional guidelines for the General Data Protection Regulation (EU) 2016/679 (GDPR). It is important to be part of the discussion as these rules develop, as many companies in the EU and beyond will encounter them sooner rather than later.
Support in Ireland
Companies that do medtech R&D in Europe and want to sell on the European market will find additional support structures – particularly in Ireland. The Irish government has put structures and mechanisms in place to help medical device companies find their way around regulations more easily, including the existing GDPR, the new MDR and IVDR, as well as any future regulations on AI and other relevant issues.
First, there are three National Research Ethics Committees (NRECs) – one for medical devices and two for clinical trials. The NRECs are responsible for submitting ethical reports in prescribed areas of health research with the aim of providing uniform national ethical provisions that are respected nationally. In addition, the Health Research Consent Declaration Committee (HRCDC) was established to evaluate and issue declarations of consent in situations where express or informed consent is not possible or in any way compromised.
The NRECs and HRCDC were designed to be accessible capital to the health research and innovation community, including the medical device industry. Working with these organizations results in the permits required for regulatory compliance, creating a single point of contact for critical support.
I have Dr. Jennifer Ralph James, director of the National Office for Research Ethics Committee, asked about her recommendations for US medical device companies. It offered the following perspective. “The EU Medical Device Regulation will harmonize the way research in this area is carried out across Member States, including a lifecycle approach to safety and a ‘risk-based’ classification that reflects current innovations in the industry. The Irish regulatory environment for medical devices will change with the establishment of a national research ethics committee for clinical trials of medical devices. “
“For US companies, it’s a good idea to start working with local European regulators, which for Ireland include the National Office for Research Ethics Committees and the Health Products Regulatory Authority,” she added.
Everyone involved wants a healthy, competitive medical technology sector and everyone wants to ensure that European citizens have access to the best medical technology products on the market. That means creating a system that companies can use to bring their best products to market in Europe.
IDA Ireland, the country’s inbound investment agency, supports companies operating in Ireland. Rachel Shelly, Head of Medical Technologies at IDA, shared how the foundations for success in the medtech sector were laid. “The aim of the new EU regulations on medical devices and in vitro diagnostics is to increase patient safety and the protection of public health in a highly innovative business environment. The new rules are driving significant developments in the regulatory system and the transition period is being used to the full by manufacturers, notified bodies, regulators and key operators. The Irish Health Products Regulatory Authority has been working with industry throughout the transition period to provide insight and guidance on the practical applications of the MDR so that we can ensure effective implementation at the national level. “
I hope that medical technology companies feel comfortable and secure as the MDR, IVDR and future regulatory measures continue. Ultimately, they should create more clarity and a level playing field for companies. Companies can feel safe in Europe as a safe business location. Guidelines and guard rails will support ethical practices and help them stay on the right side of public opinion.
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