Medical Devices Regulation (EU) - Checklist for legal teams

The non-exhaustive list below covers different areas of interest under the MDR, ranging from contracts and advertising, to product liability concerns and provides general guidance.

Intra-company agreements

• Review intra-company agreements involving medical devices and related processes to plan for the multiple new pre-marketing and post-marketing requirements imposed on all economic operators.
• Consider mandatory provisions in agreements involving authorised representatives and obligations which non-EU manufacturers should never delegate to their authorised representatives.
• Check whether or not (contractual) delegation of powers and obligations within the supply chain complies with the MDR – eg delegation of regulatory checks imposed on a local distributor to another group company.
• For manufacturers: have clauses in place to obtain mandatory MDR information from lowers level of the supply chain (eg distributors), including in relation to sales volumes, information provided by users and/or product feedback.

Agreements with third parties

• Review agreements upstream (eg with third party suppliers) and downstream (eg with service providers and external distributors) to plan for MDR requirements in the pre-marketing and post-marketing phases.
• Downstream, consider whether or not the other party (eg a customer) qualifies as a ‘distributor’ of medical devices under the MDR and organise legal obligations accordingly in the agreement.
• Upstream, consider whether the other party qualifies as a sub-contractor or supplier of products or processes covered by the MDR and organise legal obligations accordingly.

Advertising

• Ensure that teams reviewing promotional materials are trained to the new MDR requirements regarding claims.
• 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.
• Consider guidance on claims management enacted by the Medical Devices Coordination Group (MDCG) established under Article 103 of the MDR in a number of guidelines.
• 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.

Product liability

• Consider that your company can be held liable under product lability 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.

General guidance

• Understand that copy-pasting MDR provisions in agreements does not mean being MDR compliant.
• Perform legal and contractual review of template agreements prepared by Quality and/or Regulatory teams; consider whether templates are in line with the laws in force in the relevant jurisdiction(s).
• Examine the MDR requirements that apply to your company’s devices during the “grace period” and whether they qualify for a deadline extension.
• Consider local laws implementing the MDR in jurisdictions where your company is active (national rules should be notified by Member States to the European Commission by 25 February 2020 and should at least contain the penalties applicable for infringement of the MDR provisions).
• Stay on top of MDR developments by consulting the website of the European Commission (DG Grow, Unit D4) (since 1 January 2020, DG Sante, Unit B6) and European industry associations such as MedTech Europe, COCIR and Eucope.

For further background about the MDR, please see our dedicated Medical Devices page.