The Medical Device Regulations ('MDR') represent the most significant overhaul of the existing medical device regulatory framework in 25 years.
While the full implementation of the MDR has been delayed until May 2021, companies should now be using the additional time available to review their business practices to ensure a smooth transition to MDR compliance.
The non-exhaustive list below covers a number of issues that companies should consider, and actions they should take with respect to the MDR, ranging from contract reviews and advertising, to product liability concerns.
- Review intra-company agreements involving medical devices and related processes to account for the new and more stringent pre-marketing and post-marketing requirements imposed on all economic operators under the MDR.
- Consider whether, or not, the contractual delegation of powers and obligations within the supply chain complies with the MDR, for example, the delegation of regulatory checks imposed on a local distributor to another group company.
- Manufacturers should ensure that their agreements contain clauses which allow them to obtain mandatory MDR information from lower levels of the supply chain, such as distributors, including information relating to sales volumes, information provided by users and/or product feedback.
- Review upstream agreements with third party suppliers and downstream agreements with service providers/external distributors in order to plan for MDR compliance in the pre-marketing and post-marketing phases.
- With respect to downstream agreements, companies should consider whether or not the other party (perhaps the customer) qualifies as a 'distributor' of medical devices under the MDR and, if so, update the legal obligations in the agreement accordingly.
- With respect to upstream agreements, consider whether the other party qualifies as a sub-contractor or supplier of products or processes covered by the MDR and, if so, update the legal obligations in the agreement accordingly.
- Be cognisant of the fact that your company can be held liable under product liability laws in case of a failure to provide adequate warnings, which could typically characterise a "defect" in the sense of the Product Liability Directive 85/374/EEC.
- Be aware of the high threshold the MDR places on manufacturers to define not only warnings, but also precautions, contra-indications, measures to be taken and limitations of use regarding the device.
- For implantable devices, check whether the mandatory information to be supplied to the patient (including the implant card) complies with the MDR and hedges your company sufficiently against product liability risks.
- For devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, consider how your company informs users about IT security measures, including protection against unauthorised access, necessary to run the software as intended.
- Review insurance policies in line with MDR requirements to provide sufficient financial coverage in respect of potential liability under the Product Liability Directive 85/374/EEC.
- Ensure that teams reviewing promotional materials are appropriately trained in relation to the new MDR requirements and how they relate to any claims being made with respect to your medical devices.
- Ensure that all promotional materials inform users or patients of the likely risks associated with the use of devices covered by the MDR in line with their intended purpose.
- Check for local interpretations of the MDR claims regime by Member States and consider local enforcement of the MDR requirements by competent authorities in charge of device advertising. In Ireland the advertising of medical devices is regulated by the Advertising Standards Authority for Ireland.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.