knowledge 1 December 2023 |

Irish Product Liability Update –  High Risk Medical Devices’ New Regime -  December 2023

MDR broadens and intensifies high-risk medical devices regulation in the EU and in the many other countries in the world that apply or adapt EU medical device rules. MDR’s 175 pages of principles and detailed rules are directly applicable in Ireland and elsewhere in the EU. Although implementation of aspects of the regulation has been delayed, many of its key requirements are in force. Local Irish regulations in support of MDR were signed into effect in 2021. The EU will issue further implementing acts (or laws) to supplement and expand the rules in the years ahead.

Degrees of high-risk

The burden and the degree of scrutiny under MDR increases with the level of risk associated with the medical device, as designated in detailed rules set out in Annex VIII of MDR. The European Commission estimates that there are over 500,000 types of medical devices on the EU market (including in vitro diagnostic devices). Very many of these – such as walking sticks and spectacles - are obviously low-risk and are exempt from regulatory approval. Some other products, though used in surgery and other medical applications, do not require clinical investigation for approval because they are designed and made using well-established technologies (WET) with well-established safety records, where there is little evolution in their uses and the state of the art. The regulation lists sutures, staples, dental fillings, and other products under this category and the EU Commission may add other products to the category.

The Commission’s Medical Device Coordination Group has issued updated detailed guidance about what types of products are under different classes of high-risk products, and how to classify borderline cases.

Once the regulation is fully in force, all high-risk medical devices, other than those with exemptions, will have to undergo critical clinical and other safety assessments by an independent notified body before they may carry the CE approval mark.

The regulation takes account of novelty in high-risk devices. For example, in evaluating a product’s safety for Class III implantable devices with novel features, a notified body’s technical and medical experts will have to be familiar with the technology concerned and its clinical application.

All EU manufacturers of high-risk products must keep a well organised and up-to-date technical file of documents to demonstrate compliance with safety and performance requirements.

Clinical assessment is centre stage

MDR requires manufacturers of most high-risk devices to have a clinical evaluation plan (CEP) and clinical evaluation reports (CER), and to keep these up to date. Under the regulation, there is greater emphasis than previously on pre-market clinical investigation, and less scope for relying on “equivalence” - similar products’ safety records – in seeking to justify a new device’s safety. Manufacturers must conduct active post-market surveillance (PMS) and post-market clinical follow-up (PMCF) and have reliable systems for collecting and reviewing safety and performance data. Manufacturers will have to report device safety data and assessments to notified bodies, and upload safety information on the EU’s EUDAMED database. Notified bodies and competent authorities must assess manufacturers’ ongoing compliance with these rules at least annually, with unannounced audits at least every five years.

Delay in implementation

Covid, the bottleneck in designating notified bodies and the scale of the changes have delayed the full implementation of the regulation. As a result, manufacturers of high-risk devices with CE certificates issued by notified bodies under Directive 93/42/EEC (MDD) may continue to put those products on the market or into service without notified body assessments under the new regime until 31 December 2027 (for class III and IIb implantable devices) and 31 December 2028 (for other class IIb devices).

To avail of these extensions, however, the design and intended purpose of a device must remain the same in all essential respects, and there must not be unacceptable health risk. Even where the extensions apply, manufacturers of high-risk devices must apply MDR-compliant quality management systems and post-market surveillance and vigilance to the products. They must also review clinical evidence to establish conformance with the general safety and performance requirements of MDR.

Litigation risks

The regulation anticipates litigation risks, because article 10(16) provides that manufacturers must have measures in place to cover liability under the EU’s product liability regime in a manner proportionate to the risk class, type of device and the size of the enterprise.

Possible changes to that regime being assessed at present in the European Parliament and Commission would create a presumption of defect where a claimant establishes that the product does not comply with mandatory product safety requirements, such as those under MDR, that are intended to protect against the risk of the damage suffered.

Another feature of MDR relevant to litigation is the amount of information about serious incidents that will be available to the public and lawyers under article 92 and elsewhere. That article provides that EUDAMED will give the public “appropriate” levels of access to such information.

In view of their greater obligations under MDR, notified bodies may face litigation risks depending on whether under the relevant national law they have a duty of care to users of products which they certify as compliant. Annex VII requires them to have liability insurance for their conformity assessment activities.

Impact in Ireland

Larger companies, with greater resources and familiar with demanding, though different, regulation in the United States of America, should adjust successfully to the new regime. Smaller companies face greater challenges, though MDR makes (minor) concessions to help them, such as reduced fees and they are not required to have an in-house person responsible for regulatory compliance.

The National Standards Authority of Ireland is now a designated Notified Body under MDR¹. The Health Products Regulatory Authority (HPRA) as the competent authority in Ireland has new powers to support implementation of MDR, including powers of prosecution for breaches of relevant provisions of MDR².

Perhaps the main immediate challenge for manufacturers of high-risk medical devices in Ireland will be to have adequate medical and technical expertise available to meet MDR’s requirements for safety and performance evaluation of devices before and after marketing.

McCann FitzGerald LLP ©