Medical device regulation – an explainer

[UPDATE: The Independent adds some detail on the lack of data held the MHRA: “it did not have accurate data for the total number of implants inserted, making it impossible to calculate the true rupture rate.”]

Sarah Boseley provides some background to the PIP breast implants saga with a very informative piece on how implants and other medical devices are regulated.

The top angle is that these devices only require the same certification as toys, but there’s much more below that which is of particular use to anyone wanting to investigate medical devices or piggyback on the PIP story to look for similar problems.

Here are some of the key pieces of information for journalists. First, the CE mark:

“”All products must have a CE mark,” said Frederic Vincent, EU spokesman on health and consumer policy [which means they have been quality-approved by a “notified body” in Europe.] …

“Regulating the number and variety of medical devices is a huge job. The CE mark assessment must be done by one of the EU’s accredited “notified bodies”, but it does not have to be in the country of the manufacturer – the company gets to choose.

More on the CE mark at this European Commission page. (In the US, “regulation is through the centralised Food and Drug Administration, which also licenses drugs.”)

Second, the classification of medical devices:

“… The assessment is necessarily much tougher for breast implants, which have been reclassified in recent years as class III medical devices, than for bandages, for example, which are class I.”

You can find more on this at the MHRA’s page on medical devices classification.

Third, accountability: how problems are reported:

“Problems in the UK should be reported to the regulator, the Medicines and Healthcare Products Regulatory Authority (MHRA). Although the MHRA licenses drugs, it has no responsibility for approving medical devices. All it can do, if it has evidence of issues, is send out a letter warning doctors.”

Notably, the articles points out that the MHRA has in the past been unable to prevent companies marketing products they were unhappy with, “provided users and potential recipients are appropriately informed about their risks and benefits”.

Fourth: what it takes for a product to be banned:

“It takes a substantial weight of evidence of harm – which has to come from all over Europe – to get an implant banned. If there are a few cases in the UK, a handful in France and some in Italy, the regulators in each country would have to talk to the others for the problem to be taken seriously. If the company is behaving ethically, it will be the first to know because it will get complaints from everywhere and can alert the rest of the world. But a company like PIP can sit on the evidence.”

And fifth: potential conflicts of interest:

“There have been allegations that the relationships between some doctors and employees of the manufacturers are too cosy. “The device companies have tried to have good relationships with surgeons for decades,” said Alison Dennis, a partner at law firm Field Fisher Waterhouse who has long worked with the industry. “That is how devices are developed.” Surgeons advise companies and test out their products but sometimes the relationships, built up over years, go beyond the professional, she said.”

And another potentially useful body – Eucomed – and a document to frame any investigation:

“The European-wide trade body, Eucomed, set out an ethical code in 2008, requiring members not to meet doctors unless for work and not to offer rounds of golf or visits to the spa.”

You can find Eucomed’s codes (there are actually a number) here.

Are you investigating medical devices? Have you found any other useful information or organisations? Or would you like help? Please post a comment or email

One thought on “Medical device regulation – an explainer

  1. Good Morning I am carrying our a research project with very little resources
    The Causes & Effects of banned bleaching creams on the Black community 3 borough a review.
    The M.H.R.A are monitoring and working in partnership with Local authorities in some boroughs. The current penalties in place at the moment are not robust enough to provide custodial sentences for consistent offenders (retailers) profiting from the sale of damaging chemicals contained in these products.

Comments are closed.