Euro Parliament Sets Regs Changes inTrain

The European Parliament is edging towards completion of the long-awaited steps that will spell a new regime for regulating medical devices in Europe.


Newly issued monitoring and certification procedures, designed to ensure full compliance and traceability of medical devices were agreed by Parliament on Wednesday April 2nd 2014.

There’s an important piece of wordplay in the European Parliament’s news release, which makes sure we all know that the proposed legislation seeks to increase patient safety and to strengthen traceability from producer to patient. We’re to be assuaged by the promise that it will not however create additional burdens for innovative small manufacturers.

So what does it all mean in practice? Well, the sad reality is that it’s taken disasters as diverse as the PIP breast implant scandal and the failure of meta-on-metal hip prostheses to provoke these changes, no doubt because it’s easier to legislate to prevent specific events than rhetorical ones.

The European Parliament’s news release says its amendments would strengthen the procedure for placing new medical devices on the market so as to ensure that unsafe products or devices that have undergone insufficient controlled trials on patients can no longer be used on or in them. Now, quite clearly that’s an aspiration rather than a reality, as neither the word unsafe nor insufficient are anything other than judgement calls. Neither is black and white. What is happening though is that the hilariously disparate gang of inspectors that are known as Notified Bodies, people that hitherto have not even been obligated to be medical device specialists, will see their remit toughened up significantly. 

In future, MEPs say, notified bodies should have a permanent team of in-house experts who meet up-to-date qualification requirements. Overlaid on this scenario is a new group of bodies which exists to assess those class II (and above) devices considered “high risk”, for instance, devices that can be implanted in the human body.

One other measure that has received a tonne of airplay since the PIP and Hip debacles is the identification and traceability of implants. The new rules, in the wake of recent scandals, will mean patients wearing implants would also receive an “implant card” and be registered, so that they can be alerted if any incidents are reported with a similar product.

So the European Parliament has now voted on its first reading of the draft legislation, which will consolidate the work done so far and hand it over to the next Parliament.

EP Speaks 

“We talk about products that are supposed to help patients in their suffering, in their illness. We should assist doctors in making sure they are using the best and safest products to help their patients (…) Doctors have been telling us that hundreds of hip replacements are defective and have to be removed with huge expense for health systems and suffering for patients. We need a much better system”, said rapporteur Dagmar Roth-Behrendt (S&D, DE). Her report was approved by 541 votes to 19, with 63 abstentions.

Source: European Parliament


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