The introduction of the Medical Device Regulation (MDR) across Europe may lead to an increase in recall activity as the regulations start bedding in and regulators start working with the new regime.
This was the message delivered by Alison Newstead, partner in law firm Shook Hardy & Bacon International, as part of Sedgwick’s latest European Product Recall and Safety Webinar.
“Manufacturers of products which were previously unregulated or regulated under a different regulatory regime, may now find themselves faced with complying with a much more complex and stringent set of requirements,” she said.
“They will also find themselves under the scrutiny of national EU medical device regulators, who often operate differently than regulators who are entrusted with ensuring the safety of general consumer products,” Newstead added.
According to the European Medicines Agency, the MDR, which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products.
The Regulation entered into force in May 2017 and had a staggered transitional period.
The MDR introduces new or revised responsibilities for EMA for:
- medicines with an integral device, such as pre-filled syringes and pens, and pre-filled inhalers;
- medical devices containing an ancillary medicinal substance to support the proper functioning of the device. Examples include drug-eluting stents, bone cement containing an antibiotic, catheters coated with heparin or an antibiotic agent and condoms coated with spermicides;
- medical devices made from substances that are absorbed by the human body to achieve their intended purpose;
- borderline products for which there is uncertainty over which regulatory framework applies. Common borderlines are between medicinal products, medical devices, cosmetics, biocidal products, herbal medicines and food supplements.
The Sedgwick webinar also revealed that medical device product recalls increased by 6% during the third quarter to 709 (Q2: 670).
During 2021 to date, there have been 700 average recalls per quarter, up 38% on the quarterly average of 2020.
Breaking this down, there were 99 software-related recall events; 67 manufacturing-related; 61 instructions & updates related; and 60 sterility & quality related.
From a geographical perspective, Italy has seen the most medical device product recalls, with 183. This has been closely followed by Germany with 183, and then Denmark with 115.