European Parliament tightens medical device regulations

The European Parliament voted today to tighten its regulations on medical devices and diagnostics, enacting stronger post-market surveillance rules and adding a safety check for high-risk devices.

The new rules, which also mandate a unique identification system and implant cards for patients, are slated to go into effect 3 years after they’re officially published in early May for medical devices and 5 years for in vitro diagnostics.

“The metal-on-metal hip scandal highlighted weaknesses in the current system. So we’ve introduced much stricter requirements for the bodies that authorize medical devices, and will insist that particularly high risk devices, such as implants, joint replacements or insulin pumps, be subject to additional expert assessments before they can be authorized,” medical devices rapporteur Glenis Willmott said in prepared remarks. “We’ve also agreed a much stronger system of post-market surveillance so that any unexpected problems are identified and dealt with as soon as possible.

“With the PIP breast implants scandal, many women simply didn’t know if they had received defective implants or not. So we’ve also introduced a Unique Device Identification system to help trace patients, who will also be given an implant card, which they can use to access information via a publicly accessible database,” Willmott said.

The new regulations provide for random plant inspections after devices hit the market, stricter controls on notified bodies, an additional safety check for high-risk devices by expert panels, an implant card so patients can track which product was implanted and clinical evidence of medical device safety.

“Pre-market scrutiny of high-risk devices was a priority for the Parliament, so I’m particularly pleased that we successfully pushed for this and that these devices will now undergo additional assessment from expert panels,” Willmott said.

“We learned the lessons of scandals such as that of defective breast implants,” added in vitro diagnostics rapporteur Peter Liese. “Problems have occurred in other areas too, e.g. with stents that are implanted into the brain or unreliable HIV tests. The new regulation is good for patients, puts an end to fraudulent and shady producers and thus also strengthens respectable producers.

“DNA tests can have severe consequences for patients’ lives and they should not be carried out without proper information and counseling. Member states pointed out that this is first of all their responsibility and that they will therefore accept EU rules only to a certain extent. It is important that member states fulfill this obligation. We will be very vigilant on this question,” Liese said.

Serge Bernasconi, CEO of MedTech Europe, hailed the Parliament’s vote.

“The new regulations are welcomed by our industry as these will strengthen patient safety and clarify access to new and innovative technologies. Medical technologies save lives, improve health and contribute to sustainable healthcare. The Commission, the Council and the European Parliament have recognized the specific and differing nature of the 2 types of technologies when building these 2 new regulations and we welcome this vote that allows industry to begin the work needed to transition the 2 sectors to the new rules within the set timeframes,” Bernasconi said. “A lot of work has gone into these regulations and there is still a lot to do to make them a reality. The amount of effort needed from all parties to implement these revised rules cannot be underestimated. Essential elements, like notified body availability to handle the new requirements, should be dealt with utmost urgency.”

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