Expert Discussion: Regulatory Developments in Medical Devices

Following on from our webinar ‘Regulatory Developments in Medical Devices: Your Questions Answered‘, with guest speakers Elizabethann Wright and Edward Turtle from Cooley, this blog summarizes the latest trends and the most pressing questions discussed at the webinar.

The Impact of EU MDR and IVDR

First of all, the EU MDR and IVDR are both regulations, meaning, unlike Directives, they are directly and immediately applicable in EU Member States without national implementing measures. This also means that there should be more consistency in the implementation of the regulations among Member States.

A key impact of the new legislation is the change in CE Certification of Conformity. The Certification issued in accordance with the MDD and IVDD will remain valid until the end of the certificates up to 27 May 2024, while meeting the conditions specified in the MDR and IVDR. Elizabethann pointed out that this is not a renewal of the existing certificate. It is a new procedure under new legislation.

A piece of valuable advice given by Elizabethann is to act timely, contacting Notified Bodies as soon as possible, especially for in-vitro diagnostic devices. Although it seems there is still one year before the implementation of IVDR, given the increased number of IVDs requires intervention of a Notified Body and the small number of Notified Bodies that are designated to IVDR, IVD companies must be aware of the obligations and timeline for notification, and act fast.

Product Liability Risks for Business Under the New Medical Device Regulation

Edward suggested that the new medical device regulation would indeed bring changes to the nature and level of the product liability risks for businesses.

Firstly, MDR expanded the scope of EUDMED and made it publicly available. It also requires safety clinical studies and decisions on classification information to be submitted and published. Public access of this data would allow the claimants and law firms to monitor the manufacturers and bring in the claims at an earlier stage.

Secondly, MDR increases the chances of third parties other than producers being targeted and held liable for defective products, such as representatives, sellers or even Notified Bodies.

Thirdly, the regulatory standard of safety is hugely increased. There is a greater focus on safety and higher classifications. The regulatory standard would impact the assessment of defective products which is a crucial element in product liability claims.

As Edward described, the new EU MDR and IVDR are just two pieces within an ambitious jigsaw of EU reforms on the medical device sector in terms of product liabilities. There are other legislations such as the new EU Market Surveillance Regulation and the new EU Representative Action Directive that will have more significant impact.

UK Position in Light of Brexit

This is a big topic, and Edward provided some valuable observations. First of all, we could already see some divergences such as the new UKCA mark and Declaration of Conformity, registration with MHRA, as well as the statutory divergence. Although the UK regime can be continuously operated under the old EU rules, we could expect changes in the future. The UK government has been consulting on the amendments and independent medical device safety reviews and highlighting the importance of strengthening regulations in the UK. The Medicines and Medical Device Act 2021 then gives the government great powers to change the position in the UK regime. It remains a question whether this power would be used to diverge further from the EU rules or to bring the UK more closely in line with the new EU rules. Although the UK government has not expressed the intention of going down the new EU route, it did say that the UK would take into consideration international standards and global harmonization. To be closely in line with the EU approach is also desirable for many stakeholders. Therefore, we could actually expect such changes in the future.

New Developments in China

There are two key changes set out in the new Medical Device Regulation, Order No. 739, 2021. Firstly, the new regulation introduced the Marketing Authorization Holder regime to the medical device sector. This means the companies or institutions that registered or notified the medical device products will be responsible for the quality and effectiveness of the products through the entire life-cycle of the products. Unlike the previous regulation which divides the obligation into different stages, the new regulations take the life-cycle management which is much more in line with the international approach. A Marketing Authorization Holder can be a manufacturer or a research institution without manufacturing ability. Such an approach also gives R&D institutions opportunities to obtain ownership of products which encourages innovation.

Secondly, the new regulation introduced the following measures to speed up the registration process in order to allow the products to enter the market sooner:

• Prioritized review and approval pathway for innovative medical devices
• Conditional approval pathway for urgently needed medical devices that are used to treat orphan diseases or severely life-threatening diseases
• Emergency approval pathway and use of medical devices in response to pandemics such as COVID-19
• Special approval pathway for importing medical devices for urgent clinical needs
• Medical institutions are allowed to research and develop medical devices in response to emergency public incidents
• Applicants may choose to use product self-inspection report for the registration or notification of products
• Simplified notification procedure for Class I medical devices

Want to find out more? Watch the webinar on demand here.