European Commission pre-empts vote with new audit rules

The environment subcommittee of the European parliament is voting today – at long last – on proposed legislation to harmonise the approval process for medical devices in the EU. The European Commission has got the jump on this twice-postponed vote, however, and has already put into place two of the measures included in the proposals.

The measures, designed to improve patient safety, were widely expected and indeed are likely to have been put into place ahead of the vote because none of the interested parties put up any opposition. They will probably not add significant time or expense to the device approval process, and Eucomed, which represents device companies in Europe and therefore might be expected to oppose regulation at every turn, has in the past even suggested that the measures do not go far enough.

Making a boob

As of today, notified bodies, the agencies that award CE marks to devices, must conduct unannounced inspections of medtech companies’ factories to ensure the products are being manufactured safely and correctly.

And the 80 or so notified bodies will themselves be under greater scrutiny: before being awarded the power to confer CE marking they must be assessed by experts from the Commission and more than one EU country. National governments must also monitor the bodies based in their countries at intervals to ensure that they continue to meet the required standards and are indeed conducting site visits as specified. If they fail, their country’s government must withdraw their designation.

The initiatives have already drawn first blood. A pilot scheme of notified body auditing was launched earlier this year, with 11 inspections having taken place so far, and two bodies have been obliged to stop issuing CE marks until deficiencies have been corrected.

These measures have been developed in response to the Poly Implant Prothèse (PIP) breast implants scandal, where the French company was found to have used industrial-grade silicone in its implants. PIP had been inspected by a notified body, but the visits had been telegraphed in advance, giving the firm time to swap out the illegal plastic for the proper stuff.

The new rules also call for bodies to check that the quantity of finished products corresponds to the quantity of the crucial raw material purchased, where applicable, in a direct attempt to prevent another PIP.


These changes mean extra work, and workers must be paid. Notfied bodies will presumably have to put their fees up, thereby passing the cost on to industry. It has, however, been mooted that these fees may be cut for the smaller medtech firms that depend on the EU’s faster approval process to build revenue and to accumulate patient data that they can use to get approval in the US (Vantage Point – Europe set to tighten device regulation but reject central authority, September 11, 2013).

It is widely acknowledged off the record that some bodies are more thorough than others, and it is to be hoped that these new rules will force underperforming groups to pull their socks up or simply pack up. But concerns over how much of an effect this somewhat scattergun approach will have on patient safety remain, and today’s vote – underway at time of press – is likely to usher in more concrete proposals.

These new rules have appeared in the same week that saw the US FDA bring in device traceability measures (In vitro diagnostics growth to spearhead future of medtech, September 23, 2013). Whatever today’s vote brings, manufacturers must get used to the fact that regulators are getting stricter.

To contact the writer of this story email Elizabeth Cairns in London at [email protected] or follow @LizEPVantage on Twitter

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