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Update: The European Council agreed to MDR’s postponement on Monday, effectively postponing the regulation’s deadline until May 2021. The formality of publishing the postponement in the Official Journal is the last step in the process.
The European Parliament voted in favor of the European Commission’s proposal to postpone the Medical Device Regulation (MDR) until May 26, 2021. The vote is one of the last hurdles to MDR’s postponement and is considered the death of the 2020 deadline.
The final steps to postponement involve approval by the member states and publication of the postponement in the Official Journal before it will enter into force.
The postponement has been expected since Stella Kyriakides, the European Commissioner for Health and Food Safety, announced in March that the commission would propose delaying MDR, due to the resources needed to combat COVID-19.
Parliament said in a statement after the vote, “Given the current pressure on national health authorities and manufacturers of medical devices, there is a fear that there could be shortages or delays in getting the medical devices needed to fight COVID-19, were they to follow the new rules of the Medical Devices Regulation from May this year.”
Prior to COVID-19, orthopedic companies expressed concern over meeting the May deadline. Companies would be wise to press on with their implementation plans to the best that they can amid COVID-19.
Last April, we asked Erik Vollebregt, a Founding Partner at Axon Lawyers and a leading voice on MDR, about how companies should prioritize their MDR plan. Now that companies are presumably 13 months out from the deadline again, his recommendations are worth a review. We’ve provided a high-level recap of them here.
- Check whether you are working with the right Notified Body (NB) and whether this NB has applied for designation under the MDR, when they expect their designation and when they can accept your conformity assessment application.
- Check whether your product portfolio can be cleaned up to the most important and evidence-based devices in your organization, if you do not have the resources to remediate all of your devices at the same time.
- Initiate postmarket clinical follow-up activities and identify gaps in your data quality and quantity. Preferably, you have been collecting this data during the time that your device was on the market.
- Prepare your quality management system (QMS) toward the new regulation. One thing that is often misunderstood is that an ISO 13485:2016 certificate does not equal compliance with all MDR QMS requirements. The MDR requires significant extra work and a good gap analysis.
- Make a strategic choice about renewal of your current MDD and AIMDD certificates to ensure sufficient time toward transition to the new rules in the EU, if you do not anticipate significant innovation of the device in the next five years.
- Work on the implementation of the economic operator and traceability regime. You will need to review your distribution agreements and determine who has what new regulatory role under the MDR in your supply chain.
- Realize that there is no grandfathering. Every CE Mark must be renewed under the MDR sooner or later. Doing nothing is not an option if the company wants to keep placing products on the market in Europe.
Vollebregt urged orthopedic companies to act even in the face of uncertainty.
“When things remain unclear, it may still be necessary that the company acts,” he said at the time. “This is something that I’ve seen a lot with medical device companies, especially U.S. companies. If there is not an immediate very well-defined need, regulatory affairs does not get the budget to do remediation, and in the meantime the company loses precious time until it is too late for meaningful remediation. The MDR is of strategic importance to a medical device company, as its European and other international markets that rely on a valid CE Mark for the device are at stake.”
