New EU Medical Devices Regulation to Hit Nutritional Sector Claims


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

To contact our editorial team please email us at

Related Articles

Nutrition & Health News

Plasma Nutrition technology found to significantly boost bioavailability of whey protein

21 Jun 2018 --- A University of South Florida study has found that Plasma Nutrition’s Ingredient Optimized technology can make whey protein more bioavailable than high DH hydrolyzed whey protein. The research was conducted on a double-blinded randomized cohort in a crossover design and compared the effects of 25g of non-hydrolyzed ioProtein whey protein isolate (WPI) to 25g of a high-DH hydrolyzed whey protein. The results show that ioWhey Protein is more bioavailable than hydrolyzed whey protein, demonstrating a 58 percent increase in leucine absorption and 60 percent increase in BCAA absorption.

Nutrition & Health News

More than a flavor: Flavoring substances stimulate immune defenses, study finds

21 Jun 2018 --- Not only do citric acid and spicy 6-gingerol from ginger add special flavors to food and beverages; both substances also stimulate the molecular defenses in human saliva, researchers from the Technical University of Munich (TUM) and the Leibniz-Institute for Food Systems Biology have found. The findings demonstrate the potential of flavor substances to have properties that go beyond the sensory.

Nutrition & Health News

Zero proof that probiotics can ease your anxiety, research reveals

21 Jun 2018 --- Those hoping to alleviate their anxiety with the use of probiotics should probably put down that yogurt spoon or supplement bottle and call a professional instead. This is according to researchers from the University of Kansas who reviewed available research, finding evidence that probiotics can reduce anxiety in rodents, but not in humans. The researchers reviewed data from 22 preclinical studies involving 743 animals and 14 clinical studies of 1,527 individuals, and found that probiotics did “not significantly reduce symptoms of anxiety in humans and did not differentially affect clinical and healthy human samples.”

Business News

Probiotic expansion: General Mills leads investment in GoodBelly parent

21 Jun 2018 --- General Mills' venture arm, 301 Inc., is leading a US$12 million round in funding in NextFoods the parent company of GoodBelly Probiotics. Additional capital is coming from existing investors, including Emil Capital Partners. NextFoods was founded in 2007 by Todd Beckman and Steve Demos, who founded WhiteWave Foods, the owner of Silk plant-based milk.

Nutrition & Health News

DuPont microbiome venture inks third partnership on probiotics

21 Jun 2018 --- A new collaboration with Institut National de la Recherche Agronomique (INRA) Micalis-MGP will concentrate on DuPont’s probiotic strains and the understanding of these microbes’ mechanism of action on human health. The move is hoped to continue DuPonts Microbiome Venture capacity building – through strategic partnerships – in microbiome innovation.

More Articles