06 Apr 2017 --- The Council of the European Union has adopted a final version of the new Medical Device Regulation (MDR) which will handle substance-based medical devices more strictly. Consequently, substance-based medical devices will no longer be classified as class I, but will be classified as at least class II-a or II-b.
Meanwhile, the new regulation explicitly mentions probiotics (live bacteria) as no longer acceptable as ingredients for medical devices. Consequently, many of the oral medical devices currently on the market will have to either be re-classified or transferred to a new product category.
The new regulation “will impact the registration of nutritional products that qualify as medical devices. We are experiencing an [increase in] regulation of substance based medical devices that will require another level of evidence and another level of notification in order [for products] to be registered as these devices,” said Irene Wohlfahrt, Senior Consultant for Analyze & Realize.
“Medical devices so far have really been another option for manufacturers to market certain substances. Because the health claim regulation in Europe so far has not allowed claims on certain substances, such as botanicals most notably, medical devices have been an option, avoiding the health claim regulation because they are not a food per se,” Wohlfahrt said when asked about the possible pros of the new regulation for companies.
“So [currently] the health claim regulation is not applied to medical devices and what we are experiencing now is that this option is becoming harder because you have to walk a different route towards notification. [The regulation] has been upgraded, so it is currently harder. So I don’t see an upside to that [for companies],” Wohlfahrt added.
The publication of the regulation in the EU Official Journal is expected for June/July 2017.The regulation is set to come into force half a year later. For a time frame of 3 years, manufacturers can opt to certify their products either under the new MDR or under the old Medical Device Directive (MDD). After 2020, this will no longer be an option. However, existing products may stay on the market for another 4 years.
The European Parliament announced yesterday in a press release that stricter rules to ensure that medical devices such as breast or hip implants are traceable and comply with EU patient safety requirements were backed by MEPs on Wednesday. MEPs also approved laws to tighten up information and ethical requirements for diagnostic medical devices, e.g. for pregnancy or DNA testing.
"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 (S&D, UK) said.
The new rules provide for “random inspections of producers’ facilities after devices have been placed on the market.” Moreover, the new rules provide for the clinical evidence of medical device safety that needs to be supplied by manufacturers of these products.
"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.
By Lucy Gunn