The MDR is here - Regulatory changes and their impact on liability
The MDR naturally brings with it a number of regulatory changes and challenges, but it also contains provisions that can be expected to have an impact on medical device liability under the Product Liability Directive and its national counterparts. We have highlighted a few of the most relevant changes that are likely to introduce additional product liability risks below.
On 26 May 2021, the Medical Devices Regulation (EUR) 2017/745 (“MDR”) came into effect after having been postponed in 2020 due to the Covid-19 pandemic. It introduces a number of far-reaching changes that continue to challenge everyone involved, from regulators to notified bodies to manufacturers. To name but a few, the MDR inter alia introduces stricter requirements for product safety and documentation, provides for new mandatory, patient-facing information mechanisms and adds more stringent rules for the designation of Notified Bodies. In addition to these regulatory changes, the process for designation of Notified Bodies needed for the necessary (re-)certification of medical devices before voidance of current certificates in 2024 continues to be slow, with only seven notified bodies added to the EU’s NANDO database since the end of April 2020.
However, the changes brought about by the new MDR are likely to have an impact beyond their regulatory landscape:
Access to information
The MDR stresses the importance of “adequate access to information” and its “appropriate presentation” for the intended user as a means to protect public health, empower patients and enable them to make informed decisions (cf. for example recital 43 of the MDR). Unfortunately, this new aim puts the manufacturer in a position of having to ensure any information is as accurate as possible to avoid misinformation and misunderstanding (and thus potential liability under Article 6 of the Product Liability Directive 85/374/EEC), while simultaneously making such information available in laymen’s terms that are inevitably simplified. The latter in particular bears the risk of creating unforeseen expectations that could have been managed by providing more differentiated information to healthcare professionals who have the necessary experience in relaying such information to patients and can also phrase it in a manner appropriate for the individual patient. The situation is further exacerbated by the potential of public access to vigilance and post-market surveillance documents created for professional purposes under Article 92 (3) of the MDR. While the intention of empowering patients to make informed decisions is commendable, the obligation to make certain information publicly available in a one-size-fits all manner that does not take into account the individual patient’s situation might fall short of the aim.
The MDR as an indicator of reasonable safety expectations?
Even though so-called legacy products currently certified under the Medical Devices Directive can continue to be sold until the expiry of their certificates (but no later than May 2024), the delayed coming into effect of the MDR poses the question whether standards contained therein are an indicator of the reasonable safety expectations that a user was entitled to have even before 26 May 2021 (possible dates range from the original date of application on 26 May 2021 all the way back to the publication of the MDR in 2017). Manufacturers thus face the risk of being held to the MDR’s higher standards, e.g. regarding clinical trials, for products put on the market well before the MDR’s date of application. Even though far-fetched from a legal point of view, in particular in light of the fact that a product must be measured against the usual safety expectations at the time it was put on the market and does not become defective if safety expectations changed subsequently, this will not in and of itself prevent claimants from trying to sway courts to their side by basing their arguments on the new MDR.
Hybrid application of the MDR for legacy products
Under Article 120 (3) of the MDR, manufacturers can continue to place products on the market that are certified in accordance with the Medical Devices Regulation for a three-year transition period as long as they continue to comply with the old regulation. However, Article 120 (3) of the MDR also clarifies that the MDR will apply to questions of post-market surveillance, vigilance, etc. for these legacy products. As information from post-market surveillance and vigilance is of significant importance for any action taken with regard to concerns over a product’s safety, it is easy to see how the hybrid application of old and new regulatory regimes and the necessary transition may impact usually smooth internal processes and thus create liability risks. Consequently, clear communication and guidelines become more important than ever during the transition.
Increased regulatory requirements might broaden civil liability
Last but not least, the extension of market actors’ regulatory duties may also lead to a widening of their civil law liability vis-a-vis patients and users of medical devices. While the product liability directive (and its national counterparts) as such remain unchanged, decisions by the German Federal Supreme Court and, more recently, the Paris Court of Appeal on the liability of Notified Bodies in connection with the PIP breast implant scandal show that a damaged party may also rely on general tort law in connection with the respective regulatory provisions and claim a violation of the manufacturer’s or Notified Body’s regulatory obligations. Increased regulatory duties and requirements thus go hand in hand with an increased risk to be held liable for damages in case of a product failure.