Introduction

The new EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) were published on May 5, 2017 in the Official Journal of the EU. The MDR will apply from May 26, 2020. The IVDR will apply from May 26, 2022.

The new regime marks a major overhaul of the medical devices landscape that will resonate across the EU and beyond. It is, in part, a response to scandals surrounding PIP breast implants, metal-on-metal hip replacements and pacemakers, which highlighted weaknesses and gaps in the existing system. The MDR and IVDR aim to fill these gaps and to establish a more robust, transparent, predictable and sustainable regulatory framework to ensure a higher level of safety. The impact of the new regime will be felt by every medical device company operating in the EU, but the intensity will depend on the risk profile of the devices in its portfolio and, in particular, on the need to do new clinical studies. Manufacturers that have not yet carried out a gap analysis of their systems, product portfolio and Notified Body availability should start now. All stakeholders will have to deal with moving targets, given that over 80 delegated and implementing acts must still be drafted and published by the European Commission.

Immediate Impact

Prepare for post-market clinical requirements. By the end of the transition period, every manufacturer’s post market surveillance system must include a post-market clinical follow-up (PMCF) (or, for IVD medical devices, a post-market performance follow-up (PMPF)) to continuously update the clinical evaluation of the device, reflecting current non-binding MedDev guidance. For implantable and class III devices, manufacturers must draw up a “summary of safety and clinical performance” which will be validated by a Notified Body and made publically available. Manufacturers must review their systems against the new MDR/IVDR, implement all new requirements and train their staff.

Expect enhanced scrutiny and surveillance. All Notified Bodies will have to be re-designated under the MDR/IVDR and will, e.g., be required to have documented procedures regarding unannounced on-site audits of manufacturers and, when applicable, of subcontractors and suppliers. These obligations were already in the spotlight following a February 16, 2017 Court of Justice of the European Union ruling which stated that Notified Bodies are not under a general obligation to carry out unannounced inspections1.

For certain high-risk medical devices, the MDR/IVDR introduce a mechanism for scrutiny of the Notified Body’s conformity assessment: Notified Bodies will notify competent authorities of certificates granted for such high risk devices and the competent authority (and, where applicable, the European Commission) may, based on reasonable concerns, apply further procedures or request scientific advice from expert panels in relation to the safety and performance of any device. Manufacturers must have sufficient resources to accommodate such requests.

Prepare for new product groups and classification rules. Under the new regime, many definitions will change, e.g., certain groups of products for which a manufacturer claims only an aesthetic or another non-medical (i.e., cleaning or sterilization) purpose but which are similar to medical devices have been included into the scope of the new regime. Also, the definition of accessories has been enlarged; and the exception for custom-made devices will no longer include devices which are mass-produced by means of industrial manufacturing processes. Certain riskier devices (including software which drives that device or influences the use of that device) have been re-classified as class III devices. For IVD medical devices, entirely new classification rules have been introduced, categorizing IVD medical devices into classes A through D. Manufacturers must (re-)assess all their devices and determine the applicable rules. The risk of different classification decisions by different EU Member States will be reduced, as the Commission is given new powers to determine whether a specific product should fall within the scope of the MDR/IVDR.

Enhanced traceability requirements. The requirements of the non-binding Commission Recommendation 2013/172/EU have been included in the MDR/IVDR. Requirements include a Unique Device Identification (UDI) which must be affixed to and provided together with any medical device, allowing it to be identified and traced through the supply chain. Each participant in the supply chain, including distributors and importers, will have their own regulatory responsibilities. This will require review and revision of agreements, as well as increased competition law compliance efforts in relation to parallel trade.

The UDI, along with a significant amount of data such as on vigilance and post-market surveillance, will be entered into an enhanced European Databank on Medical Devices (EUDAMED) and made publicly available to enable better informed decisions of stakeholders.

Joint legal liability for Authorized Representatives. The new regime introduces legal liability of the Authorized Representative for defective devices, jointly and severally with the manufacturer, despite the fact that Authorized Representatives are not permitted to control the parameters that could lead to liability. Thus, it can be expected that the validity of the liability provisions will be invoked before national courts. In the meantime, existing contracts will need to be reviewed for thousands of manufacturers that do not have an establishment in the EU.

Moving Targets

The European Commission will need to adopt more than 80 delegated and implementing acts, e.g., with regard to clinical evaluation requirements (e.g., demonstration of equivalence), UDI rules (which may affect labelling changes) and conformity assessment procedures. Trade associations are expected to play an active role in shaping these acts.

Given that a significantly larger number of devices than before (e.g., approximately 80 percent of IVD medical devices) will now require the involvement of a Notified Body, the latter will likely require more and better trained staff. As national competent authorities are competing for the same personnel resources to be able to tackle the complexities of the new regime, a delay in re-designation of Notified Bodies under the MDR/IVDR, or even a (further) drop in the total number of Notified Bodies is expected. Medical device manufacturers must ensure now that their Notified Body will be re-designated — or begin the process of switching to a Notified Body that will be re-designated as soon as possible.

The MDR/IVDR provides that all devices will have to be re-certified. Self-certified medical devices will need to be re-certified by May 26, 2020 or 2022, respectively. For all other devices, manufacturers can rely on existing certifications until 27 May 2024. Importantly, manufacturers that do so cannot make significant changes in the design or intended purpose until the issuance of a certificate under the MDR/IVDR. Customer demand and Notified Body availability may also provide incentives to re-certify earlier rather than later.

Conclusion

This Update covers key requirements of the new MDR and IVDR, but there are many more. Competitive advantages can be obtained by companies that complete their gap analyses and secure resources early, and by actively following the 80+ acts that will give further shape to the new regime.