By Hilde Viroux, PA Consulting
The European Commission has postponed the long-awaited — and perhaps dreaded — EU Medical Devices Regulation (MDR) date of application (DoA) from May 26, 2020, to May 26, 2021 with support from both industry and politicians. However, this delay does not push out all the dates affixed to the regulation.
The DoA delay actually reduces transition time from Medical Devices Directive (MDD) to MDR, from four to three years, as the final compliance date remains May 26, 2024. Thus, the delay gives companies some breathing space, but should not divert their attention away from MDR compliance. Rather, the delay provides manufacturers more opportunity to assess their readiness and close gaps.
This article discusses general MDR concerns medtechs should keep in mind as they adjust to the new timeline, as well as four critical MDR factors to address (or revisit) moving forward.
Indeed, critical elements that demand manufacturer focus remain mostly unchanged: dossiers and labeling of Class l devices that remain Class l under the MDR must be fully compliant (by the new 2021 DoA). All manufacturers must comply with requirements relating to economic operators (i.e. the supply chain), and they must have a robust postmarket surveillance system in place.
Note that the previous statement assumes MDD certificates covering all but Class l devices are extended beyond May 2021 to allow progressive updates of the technical documentation, and that the manufacturer in question has no immediate plans for new product launches. Notified Bodies (NBs) are warning manufacturers not to stop MDR conversion of their quality management systems (QMS) and the technical documentation, as the NBs don’t have the resources to manage new certifications in three (instead of four) years.
As of May 15, 2020, just 14 NBs have been designated under the MDR, the last coming in May.
US medtechs face the additional challenge of having a more complex supply chain compared to the EU manufacturers, who only have to deal with distributors. Thus, US medtechs need to secure an EU Authorized Representative in addition to finding one or more importers for their products. This increased complexity reinforces the need for full transparency on product flows into and within the EU, making clear the role of each economic operator and ensuring they meet MDR requirements.
More specifically, four key factors should be in medtechs’ crosshairs as they react to the MDR delay and plan for the future:
- The dossiers and labeling of Class l devices that remain Class l under the MDR must be fully compliant by May 2021. If they are not, manufacturers may consider building a safety stock in the EU, taking into account that this stock cannot be in the ownership of the legal manufacturer. All other classes of devices can continue to be sold under a valid MDD certificate until May 2024 or the MDD certificate’s expiry date.
The MDD certificate’s expiry date will determine when the product’s technical documentation and the QMS have to be fully compliant. It is recommended to establish, in concert with the NB, a plan for conversion of all products to MDR compliance if that plan is not in place already.
- Manufacturers need to identify the various economic operators in their supply chain. The economic operator’s (e.g., importer or distributor) role can vary with the product flow. A distributor can become an importer if the product is received directly from the EU. Importers and distributors must perform checks on the product. However, checks performed by an importer are different from checks assigned to the distributor.
Distributors that repackage products or add instructions for use (IFU) in the local language now need a QMS covering these activities, which must be verified by a NB in order to continue said activities after May 26, 2021. Manufacturers need to update distributor and importer contracts to reflect the MDR requirements.
On a positive note, this exercise provides an opportunity for manufacturers critically assess their supply chains and product flow into the EU, identifying opportunities for simplification and cost reduction. This is critical, as the additional MDR-mandated verification and labelling activities will increase cost of importing and distributing in the EU.
- Proactive postmarket surveillance requires manufacturers to reach out to their client/user base to collect information on the use and safety of their devices. The practice of collecting postmarket information via the complaints system is not sufficient; NBs will focus on postmarket surveillance activities during the annual surveillance audits.
In addition, transparency relevant to a manufacturer’s compliance with MDR requirements is increased by bi-annual Periodic Safety Update Reports (PSURs), which in the future will be posted on EUDAMED and may be accessible to the public. According to a May email to members of the EUDAMED working groups, the EU Commission will begin making some Eudamed modules — including the modules for actor registration, UDI, and NBs — available next year. EUDAMED’s DoA was delayed until May 2022 prior to the COVID-19 pandemic and remains unchanged.
- The role of the Person Responsible for Regulatory Compliance (PRRC) is new, and its responsibilities are typically shared by multiple functions, especially in large organizations. There can be more than one PRRC in an organization, but their individual mandates and authority need to be clearly defined. The PRRC has to be part of the legal manufacturer’s organization, and the manufacturer’s PRRC cannot share responsibilities with the PRRC of the authorized representative.
Additionally, consider that medtechs must have strategies in place for updating their QMS systems, as well as documented plans for the NB certification audits. Planning for product technical documentation and labelling updates needs to consider the validity dates of MDD certificates, time for assessment by the NB, and the time it will take to bring the products with updated labelling into the EU market.
The EUDAMED implementation postponement allows manufacturers more time to collect the data required for device registration, as well as implement a change control system for these data. The processes for collecting pre- and postmarket clinical data need to be reinforced to meet the new requirements.
The MDR continues to be the most significant and impactful legislative change to medtech in decades, and May 2021 will be here sooner than you think. The above requirements are just the beginning of the compliance journey.
About The Author
Hilde Viroux is a medtech expert at PA Consulting and a leading expert on the European Medical Devices Regulation. She is a senior leader with a broad experience in regulatory, quality, manufacturing, supply chain, and project management in the pharmaceutical and medical device industry.