The recently published global investigation by the International Consortium of Investigative Journalists into the medical device sector has brought increased focus on the safety of medical devices. The so-called ‘Implant Files’ will likely draw significant public, media, governmental and regulator attention to medical device safety and regulation. That may in turn heighten litigation risk for manufacturers.
Regulation 2017/745 on Medical Devices (MDR) was agreed by the European Council, the European Parliament and the European Commission. MDR entered into force in May 2017 and will be fully adopted in Ireland by 2022. MDR places enhanced obligations on manufacturers to provide the Health Products Regulatory Authority (HPRA), Ireland’s national regulator, with pre-clinical and clinical data to include the results of engineering, laboratory and simulated use tests relating to new products.
Transparency is the guiding principle of MDR and manufacturers will be required to upload technical documentation relating to their device to the European Data Bank on Medical Devices (EUDAMED). This will allow all member states to analyse this data and, in some cases, this data will also be made publically available.
Impact on manufacturers
Compliance with MDR is a pre-requisite to accessing the EU market. Accordingly, it is vital that manufacturers of medical devices engage with the Irish National Standards Authority (INSA), Ireland’s notified body, as soon as possible in order to ensure a smooth transition to the new regulatory framework.
In summary, MDR will require that manufacturers perform significantly more pre-market clinical evaluation of their products, producing more evidence as to their efficacy and safety than is currently required. MDR also places enhanced obligations on ISNA to:
- Assess manufacturers’ clinical investigations
- Carry out pre-market assessment and surveillance audits
- Consider the validity of any claim made to equivalence with existing products, and
- Monitor post-market surveillance
Manufacturers must also be aware that devices already being marketed in Europe may be subject to re-classification under MDR. In circumstances where devices are ‘up-classified’ they will likely attract additional scrutiny, perhaps in relation to the available clinical data, to ensure compliance with MDR. In practical terms, this means that devices which are subject to re-classification will require the allocation of additional resources to ensure that they can continue to be marketed post-MDR.
In light of this, the adoption of MDR may result in the removal of a number of legacy devices from the EU market, as a result of commercial considerations around the cost of ensuring that they are compliant.
The ‘Implant Files’ and the publicity attached to them may also represent a litigation risk. In Ireland, the principal product liability statute is the Liability for Defective Products Act 1991 (the 1991 Act). An injured person must, in respect of any defective device, prove the damage, the defect and the causal relationship between the two. Wrongful exposure to an increased risk of injury will not, in itself, constitute a legitimate reason to litigate.
The constant – and necessary - strain between innovation and regulation is reflected in the ‘development risk’ defence, also known as the “State of the Art” defence”. This is one of the key defences available to defendant manufacturers in product litigation. Essentially a defendant will have a full defence to an action where they can show that the state of scientific and technical knowledge at the time when the product was put into circulation was not advanced enough to enable the defect to be discovered.
Manufacturers should also be aware that Irish regulations make it a criminal offence to place unsafe products on the market.
MDR aspires to focus the attention of both medical device manufacturers and regulators on patient safety and quality management and to make medical device certification more transparent.
Compliance with the new regulatory framework will require the allocation of significant resources. Manufacturers should now engage with MDR in order to ensure they sufficiently understand its impact on their business and supply chain. This will allow for the development and implementation of a robust plan for compliance. Increasing litigation, regulation and scrutiny represent significant challenges for manufacturers.
It is crucial that we maintain an environment within which innovation can flourish. Without that innovation the life-saving therapies of the future will never see the light of day, to the detriment of us all.