Medical Device Regulation in 2023: A Window of Opportunity
Interview with Alira Health’s Regulatory Team
The Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (so called Medical Device Regulation -MDR-) became fully applicable beginning in May 2021. The transition period, during which manufacturers must recertify medical devices in accordance with the new regulation, is scheduled in principle to last until May 2024. Manufacturers have been under pressure as they try to navigate the complex details and attempt to comply with the new requirements.
We spoke with our team of regulatory experts about the recent news regarding the MDR and the opportunity it presents to device manufacturers in 2023.
Can you give us a brief overview of what was going on with the MDR in 2022?
Throughout 2022, many stakeholder organizations such as MedTech Europe, EUCOPE, and SNITEM published studies emphasizing that the transition to MDR compliance was not going well as manufacturers realized that they did not have the capacity or, in some cases, the capability to meet the 2024 deadline. As a result, there is a major risk of supply disruption which could adversely affect the patients that rely on these devices.
What is more, both manufacturers and regulatory consultants working with devices were overwhelmed with new guidance from the regulatory working groups in the past year, especially from the Medical Device Coordination Group, which issued over 30 guidance documents in 2022.
Another source of stress in 2022 for manufacturers was Switzerland and the United Kingdom. Both have their own new regulatory frameworks. The UK has been forced to extend their transition period for manufacturers, and for now, EU certificates are accepted. Switzerland may open the door to accept devices certified in the US by the FDA, giving US manufacturers access to that market.
What impacts are we seeing from the European Commission proposal, issued in December, that would extend the transition period for MDR compliance?
Driven by the information coming in about the difficulties facing manufacturers and the risk to patients, this proposal would delay the transition periods of the MDR, depending on the risk class of the device. For example, those with Class III or IIb implantable devices will have until December 2027 to comply, and the new deadline for Class Im, Is, Ir, IIa and IIb (non-implantable) devices will be December 2028.
Some key aspects of the proposal include:
- Manufacturers will have to demonstrate that they are well on the way to MDR compliance by meeting new requirements that are outlined in the text. For example, a manufacturer’s Quality Management System (QMS) should already be compliant in order for them to benefit from the extension.
- Manufacturers also must have an agreement in place with the Notified Body that their device will be reviewed on time. So while the new proposal does grant further time to prepare, it is not without its own requirements. The “sell-off” provision for devices would be cancelled.
- Expired certificates could be reactivated; again, with specific requirements for manufacturers to prove that they are well on their way to MDR compliance.
What will happen next with MDR?
We don’t think there will be major changes to the text of the European Commission proposal, and expect the final text to be adopted and made applicable within the next weeks.
Throughout 2023, new guidance will be published by the regulatory working groups such as MDCG, as well as guidance about the UK and Switzerland from the respective regulatory bodies. It’s difficult for manufacturers to keep up. The guidelines complement the legal text and clarify the requirements – although sometimes, they can create even more questions. One of the MDR requirements is that manufacturers demonstrate that they have a system in place to track all the guidance that is issued and understand if and how it impacts their devices.
How can medical device companies navigate this MDR situation right now?
Assuming the European Commission proposal is approved, our advice to manufacturers is that you should prepare to demonstrate that you’re well on the way to MDR compliance in order to benefit from the extension. The first step is to read and understand the legal text of the proposal, how it affects your device(s), and how you can comply with the extension deadlines. After that, you should conduct a gap analysis, identifying what requirements have not been implemented, and defining a plan to close that gap. Note that if you have multiple devices, you may have to prioritize them.
All the economic operators – the distributor, the manufacturer, the importer – must comply, so you also need to make sure that your stakeholders are aligned with you.
How can Alira Health help?
This is a complex situation, and many companies are feeling lost. We’re already helping manufacturers who are asking, Do these new requirements impact my device? Will I be able to benefit from what’s outlined in the proposal? What should I do next? As regulatory consultants, we can help them manage the transition to both the MDR and IVDR by identifying and prioritizing the requirements, building a strategy, implementing the scientific requirements, and understanding the impact of the proposed extension. We believe that the proposal opens a window of opportunity for successful implementation of these regulations and that manufacturers will ultimately succeed in reaching compliance.
If you have questions about MDR, please contact our experts.
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