The regulation of medical devices in the European Union is a national competency, unlike with pharmaceuticals, which are regulated centrally by the European Medicines Agency.
Each member state has a regulator, which in turn authorises notified bodies which can award CE marks. The mark indicates the product conforms with the health, safety and environmental protection standards of the European Economic Area which includes the EU plus Iceland, Liechtenstein and Norway.
The CE mark awarded by a notified body in one member state allows the product be marketed across the union. Furthermore, the awarding of a CE mark also serves to open up other markets around the globe, where many poorer countries are reliant on the EU and US regulatory regimes.
In Ireland the regulator is the Health Products Regulation Agency (HPRA), which has authorised the State-owned Irish National Standards Authority to act as a notified body.
Other jurisdictions have more than one notified body, and some of these notified bodies were commercial operations reliant on the fees they received from the manufacturers whose products they were able to grant or deny access to the market. It was a system that was only as strong as its weakest link.
As part of the EU reforms now being rolled out, there is increased cross-auditing of different member states’ regulatory bodies and notified bodies, as well as increased oversight by the European Commission. This, and new, higher standards that are being imposed, has seen a reduction in the number of notified bodies in the EU from 81 to 56 over recent years.
Fine Gael MEP Mairéad McGuinness, vice-president of the European Parliament, was actively involved in the reform process. The metal hip controversy, and the PIP breast implant scandal, caused the EU to take a closer look at a regulatory system that did not appear to be working. “The notified bodies and their relationships with industry was one of the questions raised,” says McGuinness.
Officials from the commission’s directorate on health and food safety, which is based in Co Meath, went out to the member states and closed down a number of notified bodies, she says, some of which were “not fit for purpose”.
Now that a more robust system is being put in place, the challenge is to get the people with the required skills. “People want less bureaucracy but more safety, but that takes more regulation and it takes resources,” says McGuinness.
Brexit effect
Brexit is not helping matters as the UK’s four notified bodies currently account for a large proportion of the new medical devices that get CE marks ever year. It is likely the UK notified bodies will open offices in other EU member states so they can continue working, but the disruption is another complication at a time when the system is undergoing reform, the number of new technologies seeking certification continues to grow, and the number of notified bodies is being reduced.
“The industry is moving so fast and so furiously,” says McGuinness. “There is a need to draw people out from industry to work on regulation, as no one else would know the necessary detail.”
Medical devices are often not screened by way of clinical trials before they are approved for the market, in the way new drugs are, but this is because they act in a fundamentally different way, says Dr Niall MacAleenan, head of the medical devices section at the HPRA.
Innovative devices that have been developed over recent years have transformed medical services, saved and extended countless lives, and provided ways to ease the suffering of huge numbers of people with chronic conditions. Stents have transformed cardiac care, while insulin pumps, pain-management devices and improved prosthetics have brought relief to tens of millions.
In part because medical technology has been so successful, the devices that are now available are often inside people’s bodies for years, if not decades. Also new, high-risk technologies introduced for people with conditions likely to cause death if not untreated sometimes become less risky as they are developed over time and surgeons become more skilled at implanting them, thereby changing the risk-benefit analysis.
For these and other reasons, new devices are often allowed on to the market after serious laboratory-based and other testing, but without being tested on humans. The manufacturers are then obliged to monitor their use and to report back to regulators any apparent problems that may be coming to their notice. This is called “post-market surveillance”.
The regime involves the making of “risk-benefit” estimations, says MacAleenan. With implanted devices especially, “there is always risk. The question is if it an acceptable level of risk.”
Adverse incidents
Over recent years manufacturers and doctors have been reporting more than 800 adverse incidents a year to the HPRA. These are adverse medical events which would not be expected, ie a sudden failure of a device as against, for example, a patient who had a very severe cardiac condition dying of a heart attack. Many of the ensuing investigations have established either a definitive link with a medical device, or a conclusion that a device was probably or could have been a contributory factor to the adverse incident. No deaths have been definitively found to be directly attributable to a medical device over recent years, MacAleenan says.
Frequently the response to such incidents is the taking of what is called a “field action”, which might be renewed or revised advice on the use of the device, or alterations to its nature.
An interesting feature of the reports is that in between a fifth to a quarter of the incidents the device has not been retrieved from the person who suffered the adverse incident, and so it cannot be examined by the HPRA investigators.
“Incident reports are not the be-all and end-all of what we do and are only part of the post-market surveillance,” says MacAleenan. The manufacturers are audited to ensure they are properly collecting information about their products and responding to any difficulties that may be emerging.
The resolution of a lot of the problems identified is most often arrived at from dialogue between the manufacturer and the regulator, and often involves solutions suggested by the manufacturer.
Medical devices are not like cars or other machines that can be withdrawn from the market without serious negative consequences if a problem is identified. Often the devices are providing crucial benefits to people who are in dire need of care, and the identified flaw feeds into a new risk-benefit analysis.
“Medical technology has completely changed the treatment of so many different conditions,” says MacAleenan. “Many areas of medical care have been revolutionised.”
The expectation is that the revolution is going to continue and that the medical device sector is set to involve a lot more connected technology, which will collect data from, and deliver instructions to, sophisticated medical devices. (The former US vice-president Dick Cheney had his heart device’s wireless capability switched off so it could not be hacked by terrorists anxious to kill him.)
More and more devices are being managed by lay people and are being controlled outside hospital environments.
The reformed EU regulatory regime for medical devices creates challenges for the sector and is likely to see an increased level of clinical screening, and increased amounts of information becoming available to the public, says MacAleenan.
The challenges facing the regulatory system arise from the new improved regime, but also the changing nature of the technologies being produced by an innovative sector that shows no signs of slowing down.
