Ahen the Covid-19 crisis is still not over, let’s keep in mind the first lesson it taught us: anticipation is the key to any effective health policy.
However, a health crisis is currently pointing the tip of its nose. It runs the risk of a shortage of medical devices (prostheses, implants, stents, pacemakers, blood bags, etc.) for European patients. Faced with such a danger, governments and the European Commission must act as quickly as possible.
Priority must be given to patient safety. In operating rooms, doctors are worried about the future: medical devices could run out. In question ? The difficult implementation of a new European regulation relating to medical devices (in English Medical Devices Regulation, MDR), entered into application on May 26, 2021.
Adopted in 2017 following the major breast implant scandal in France and Germany, it improves patient safety by strengthening the certification requirements for medical devices in Europe, an objective that no one calls into question.
An untenable schedule
According to this regulation, by May 26, 2024, all medical devices circulating in Europe must obtain a new certification, whether they have been used in European operating rooms for years or are subject to a first marketing.
The problem ? Due to additional regulatory requirements, the number of organizations able to issue these certifications has been halved compared to the pre-2021 period.
As a result, the time required to obtain certification continues to lengthen and reaches an average of twelve to eighteen months. The queue is enormous: more than 24,000 medical devices authorized for years must be recertified within less than two years, at the risk of being withdrawn from the market.
This situation presents a triple risk.
The first risk is that of shortages. Each of us is regularly asked, for example, to donate blood. It is an absolutely essential gesture, but which would become useless if the blood bags did not obtain the renewal of their certification, thus creating an unprecedented shortage of blood in Europe.
The risk of regulatory uncertainty
Other tragic situations, patients arriving at the emergency room with heart pain may not be offered pacemakers or stents, for lack of approval, while diabetic patients may face a lack of availability of insulin pumps. A few examples among many others…
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