EU Rule Presents New Medical Device Compliance Hurdles – Sylvie Gallage-Alwis

By Sylvie Gallage-Alwis

Partner Sylvie Gallage-Alwis and principal Marta Villarraga at Exponent Inc discuss how EU Medical Device Regulation 2017/745[1] of the European Parliament and of the Council of April 5, 2017, will soon become fully applicable, providing for a new legal framework for manufacturers, distributors and notified bodies of medical devices. They further provide practical tips for manufacturers to consider as the countdown is almost over, in Law360.

Sylvie and Marta’s article was published in Law360, 15 January 2021, and can be found here.

European authorities have historically taken a softer line when it comes to the regulation of medical devices. However, a revolution is about to take place.

On May 26, EU Medical Device Regulation 2017/745 of the European Parliament and of the Council of April 5, 2017 will become fully applicable, providing for a new legal framework for manufacturers, distributors and notified bodies of medical devices. The scale of this change is quite significant. Here are some practical tips for manufacturers to consider as the countdown is almost over.

The Legal Underpinnings of This Regulatory Revolution

The medical device industry has been shaken up by several landmark decisions at member states and EU levels. The Court of Justice of the European Union has, for instance, ruled that:

Where it is found that products belonging to the same group or forming part of the same production series … have a potential defect, such a product may be classified as defective without there being any need to establish that that product has such a defect.

The court further found that “in the face of evidence indicating that a medical device may not comply with the [legal] requirements … the notified body must take all the steps necessary to ensure that it fulfils its obligations.”

Manufacturers and notified bodies have therefore been the target of court proceedings aimed at determining the scope of their liability should an issue occur in relation with a medical device, with courts making it clear that the compensation of plaintiffs is the priority.

Bearing this context in mind is key when understanding and implementing the new regulation given the reinforced obligations. One of the key aspects for professionals will be the documentation to demonstrate, if necessary, that they have complied with their obligations and that their products were always compliant with the scientific knowledge available.

An Urgent Need to Adapt Infrastructure and Data Collection

Increased documentation requirements create an obligation for manufacturers to adapt and update their infrastructure in order to have quality record drafting and recordkeeping, to take into account their new obligations, factor in the new classifications and the requirements to be implemented in order to comply (i.e., risk management, quality management, medical and regulatory compliance expertise).

Manufacturers should aim to implement automated processes whereby information is recorded at each stage of the device development and alerts are sent to the operators when an update, audit or review should be conducted. For those who are unable to implement such a burdensome system, it is likely that new companies will be created to support manufacturers with these tasks.

Article 10 of the new regulation lists the manufacturers’ obligations, which include:

  • Establishing, documenting, implementing and maintaining a system for risk management;
  • Conducting a clinical evaluation;
  • Drawing up an EU declaration of conformity;
  • Ensuring that procedures are in place to keep series production in conformity; and
  • Having a quality management system in place with a strategy for regulatory compliance, management responsibility, product realization, including planning, design, development, production and service provision, etc.

Article 10 should be read closely alongside Annex 1 which details the new general safety and performance requirements. No flexibility is left to manufacturers anymore. Strong data collection will be the minimum required by the market surveillance authorities.

Not All Legacy Devices Are Exempt

As a matter of principle, when the new European Medical Device Regulation comes into force, all products placed on the EU market before that date can remain on the market as they are. The EU MDR however includes a requirement to review the compliance of medical devices which are already on the market and that will be placed on the market after May 26.

Manufacturers should first check if their devices still fall within the same classification. They should further check the type of clinical evidence they have and perhaps make difficult choices regarding keeping or removing some legacy devices from the EU market. All postmarketing requirements must be met by May 26, for all devices, even if these devices are still being distributed with a Medical Device Directive CE mark.

Plan for Delays

The new regulation contains both a chapter — Chapter 4 — and an annex — Annex 7 — specific to notified bodies detailing increased obligations and requirements. Annex 7 states that:

Notified bodies shall have the necessary personnel and possess or have access to all equipment, facilities and competence needed to perform properly the technical, scientific and administrative tasks entailed in the conformity assessment activities in relation to which they have been designated.

However, as of today, not all notified bodies operating under the Medical Device Directive have been registered and recognized pursuant to the new regulations. This is a challenge given the crucial role they play in the development process and allowing the placement of medical devices on the market.

The challenge with this dramatic reduction of available notified bodies under the MDR is that the ones which are recognized are currently overwhelmed with requests that will strain their current resources. To add to the current complexity, the COVID-19 pandemic has impacted the availability of qualified personnel and made the feasibility of in person audits more challenging.

Alternative audit mechanisms, such as virtual audits, are an option but require proper planning and resourcing. The EU commission has already issued two guidance documents earlier this year in April and December related to audits during the ongoing COVID-19 pandemic.

Therefore, there is a need to plan ahead and to make tough decisions as to which devices are a priority, which ones should not be marketed anymore, which ones may not need immediate attention from a notified body, etc. This process includes planning from the part of manufacturers to identify for each of their product lines what steps will have to be implemented to ensure compliance with the EU MDR after May 26.

Take an Active Management Role

The above developments, which only address a few of the many new requirements that will come into force in May, indicate that the top management at medical device manufacturers will have to get involved, if they have not already.

The newly imposed requirements should not be underestimated as they are numerous and complex. Teams will need to be reorganized, new responsibilities will have to be defined, a system to oversee compliance with the continuing obligations during the lifecycle of medical devices will need to be established, and the involvement of the legal team will be key.

Tough decisions will also have to be made to ensure that key devices continue to be lawfully placed on the market after May, while taking into account the increased workload of the notified bodies, the fact that the market surveillance authorities will be implementing a stringent approach to the new regulation and the continued challenges posed by the COVID-19 pandemic.

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