Changes to look out for in Medical Devices Regulations

In April 2017 the new EU Medical Devices Regulation and the EU in vitro Diagnostics Regulation (together, the ‘Regulations’) were adopted by the European Parliament, entering into force on 25 May 2017. The Regulations state that fundamental revision of the legislation is intended to provide a ‘sustainable regulatory framework for medical devices which ensures a high level of safety and health while supporting innovation’.

Further, they aim to ensure the smooth functioning of the internal market as regards medical devices, with a high level of protection of health for patients and users, taking into account the businesses that  are active in the sector. But why  was change needed?

Catalysts for change

When the previous legislation was adopted in the 1990s, it aimed to ensure the smooth functioning of the internal market and high health and safety levels. However, there have since been several key moments that, some have argued, highlight the shortcomings of this legislative framework.

Changes in technology

New methods and technology have been and continue to be introduced, not least in the development of medical devices software. Technological advancements have also increased the complexity of medical devices, and the regulatory system needed to evolve to reflect this.

PIP

In 2000, it was discovered that Poly Implant Prothèse (PIP) had been using industrial-grade silicone instead of the medical-grade specified for the CE mark in the manufacture of breast implants. The CE mark for PIP implants was consequently withdrawn, and clinicians and cosmetic surgery providers were asked to cease using them. It was reported that around 300,000 women in 65 countries were affected. The UK Department of Health undertook a review into the scandal and the actions of the Medicines and Healthcare Regulatory Agency (MHRA), ultimately concluding that PIP deliberately concealed its use of non-approved filler material, and that there was no evidence that the MHRA or the Department of Health significantly failed to
do their job.

The European Commission has stated on its website that ‘the incident concerning fraudulent production of the PIP silicone breast implants highlighted weaknesses in the legal system in place at the time and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices’.

DePuy

In August 2010, two types of metal-on-metal hip implants manufactured by DePuy were recalled worldwide after data revealed that more people than anticipated had experienced problems and required a second hip replacement. DePuy then announced a voluntary recall of its ASR metal-on-metal hip replacement system after a study showed that the five-year failure rate for the product was about 13%. There were concerns that the failing hip replacements were leaking chromium and cobalt into the bloodstream and causing increased cancer risk in patients. Unlike PIP, DePuy is not expressly mentioned by the European Commission as highlighting the need for the new Regulations, but is another example of a medical device incident that caused a fear for patient safety.

There are differing views on the extent to which amendments to the regulations can effectively deal with the issues highlighted in the scandals set out above.

Lord Howe, Parliament Under-Secretary of State, Department of Health stated in relation to PIP: “We must always remember that we are dealing there with a clear case of fraud. It was clear from my investigation that no amount of regulation could have prevented deliberate fraud of that kind.”

The UK Medicines and Healthcare Regulatory Agency (MHRA), gave a more nuanced view:

“Issues from PIP silicone breast implants and metal-on-metal hips stem from very different root causes - the first from deliberate subversion of the regulatory system and the second from unanticipated wear over a long time-period. […] any regulatory framework has room for improvement and it is important for lessons to be learned from all instances where devices cause harm to patients. Equally the regulatory system for medical devices does need to evolve to reflect increasing complexity of devices.”

On the other hand the European Parliament on 14 June 2012, adopted a resolution which appeared to see regulatory change as vitally important, stating that it “urgently recommends a revision of the Medical Devices Directive aiming at introducing a capacity to detect and minimise the risk of fraud, focusing in particular on provisions regarding market surveillance, vigilance, and the functioning and tasks of notified bodies, so as to avoid a repetition of the PIP case”.

It is therefore worth looking at the changes that are implemented by the Regulations in order to assess whether they might effectively address these issues.

Changes under the Regulations

The changes made by the new Regulations can be broadly split into three categories:

1.  broadening the scope and reclassifying the devices captured by the Regulations

2. seeking to enhance the transparency and accountability of all suppliers in the medical devices sector, and enhancing vigilance and

3.  seeking to ensure accountability for all actors in the supply chain.

Broadening scope and reclassifying

By broadening the definition of medical devices, a wider set of products will now fall within the scope of the Regulations. A key change expressly includes software as a ‘medical device’, addressing concerns that the previous legislation was not up to date with the latest technological changes. The Regulations also extend to products without an intended medical purpose such as contact lenses, equipment for liposuction and lasers for skin treatments. In addition, certain devices will be reclassified into higher-risk categories, meaning they will now require approval from notified bodies.

Enhancing transparency and vigilance

Under the New Regulations, each device will be required to have a unique device identifier (UDI) which will then be logged on the European database (EUDAMED). Such a database should give a ‘live’ picture of devices as they progress through the supply chain. This will help  to detect counterfeit devices and  to ensure that, where a counterfeit  is distributed, any product recall  is effective.

In addition, there will be enhanced market and post-market surveillance which it is hoped will improve the safety of the devices and provide clear incentives for businesses to comply with the Regulations. Regulatory authorities will be able to conduct audits and make unannounced visits.

Notified bodies also will be subject to heightened requirements, including a redesignation process and consistent reassessment to check that the notified bodies
are effectively monitoring and enforcing requirements.

Accountability throughout the  supply chain

For the first time, all actors in the supply chain have potential responsibility for any defect in devices, compared to the old Regulations which focused on the liability of manufacturers. Entities outside of the EU will need authorised representatives within the EU against which regulatory action might be taken.

Do changes meet the objectives?

The Regulations have been changed to reflect technological changes, - particularly in that they have been updated to include software. On the other hand, given the exponential growth of technological change (and particularly the anticipated impact of artificial intelligence) future-proofing is arguably becoming increasingly challenging.

On the extent to which the regulations might prevent future scandals in relation to medical devices, we can only wait and see. For one, the final implementation dates are not until 26 May 2020 for medical devices and 26 May 2022 for in vitro devices, and it will be some time before the changes’ full impact is felt.

But, of course, considerable regulatory changes of this kind are likely to have an impact. Changes that are likely to be noticed include the broadened scope and reclassification of products necessitating a significant review of entities’ product lines and widespread due diligence; liability throughout the supply chain leading to parties renegotiating contracts, assessing where liabilities may lie and potential litigation; and the reassessment of regulators and new powers possibly leading to more regulatory investigations.

So, this is certainly likely to lead to a greater compliance burden, and companies will need to take this into account. There is likely to be more scrutiny of a wider class of products.
It is foreseeable that these changes could lead to more, not fewer, issues being uncovered.

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