Joerg Gruenwald, analyze & realize ag06.02.14
For years, the medical device category has served EU health product manufacturers as a possible alternative to drug products and food supplements. All that is required to market medical devices is a certificate of free marketing within the EU (the CE mark or Declaration of Conformity), which is basically a certificate of safety. Also, medical devices only require a limited proof of efficacy compared to drugs, which makes their development less expensive than that of pharmacological drugs.
Medical devices are explicitly intended to diagnose, prevent or treat diseases, allowing strong claims to be made, which makes them more attractive than food products, including supplements, from a marketing perspective. As Class I, Class IIa or Class IIb devices, they can, for example, be formulated as orally taken tablets or capsules; they can even be combined with pharmacologically active substances (Class III), as long as their main mode of action is physical rather than pharmacological. This makes their appearance virtually indistinguishable from food supplements to the consumer.
The demarcation between an oral medical device and a food supplement is a blurry one. For Class IIa, IIb and III medical devices, a Notified Body—the authority that grants the CE mark to a new medical device—will make a decision on whether the main action of the product is physical or pharmacological. Some Notified Bodies will judge this more harshly than others, which is why manufacturers often have their preferred Notified Bodies.
Change on the Horizon
Soon, however, all this is going to change. After all, in the 20 years since the Medical Device Directive was drawn up, the EU itself has changed, acquiring more member states and becoming more harmonized. More importantly, medical device technologies have advanced. Especially in implant technology, new safety issues have resulted in the necessity of revising the old directives. Thus, the Medical EU Directives will be replaced by the Medical Device Regulation, with far reaching consequences.
For one thing, all Notified Bodies will lose their status as such. In order to become a Notified Body in accordance with the new regulations, all organizations will have to re-apply. The new regulations will emphasize the clinical evaluation part of the certification process; Notified Bodies will have to employ qualified staff specialized in the areas of effect for the various medical devices that are submitted.
At the same time, all Declarations of Conformity previously granted according to the EU Medical Device Directive will become invalid. This means that all medical devices in use today, from latex gloves to implants to oral medical devices, will have to re-apply for their CE mark (with the newly re-authorized Notified Bodies). These applications will then be evaluated according to the new regulation, which may very well mean that many Class IIa, IIb or Class III medical devices that barely slipped past the device/drug demarcation will not receive a CE mark again, and thus not a marketing authorization as a medical device.
Of course, before all this comes into effect, a suitably long transition period is expected to be implemented, as the workload of merely re-certifying every medical device in the EU is going to be immense.
Conformity vs. China Export
While we are on the subject of the CE mark, here is an interesting fact. The CE mark is a mark of conformity that is used extensively in the EU to denote conformity with all sorts of regulations. Marks are found not only on medical devices, but also on all electric or electronic appliances, where they signal to consumers that the device in question has passed testing and therefore is safe to use.
The logo CE (China Export) looks almost exactly the same, down to the rounded shape of the E and the proportions of both letters. The only difference is that both letters are slightly closer together in the China Export logo than they are on the European Conformity logo. Both logos are so similar that you have to be aware of this difference in order to spot it.
The China Export logo, not surprisingly, is embossed on all products manufactured in China and exported into the EU, such as children’s toys, and of course, electronic devices. It does not denote conformity with any regulation, nor is it a symbol of safety. However, the end consumer can hardly fail to mistake it for just that, and to assume a safety of use that may not exist.
Moving Forward
With the revision of the medical device regulatory situation in Europe, it may be worth it for manufacturers to re-think their product strategy with oral medical devices. It seems likely that many former Class IIa, IIb and Class III medical devices may not be granted medical device status under the new regulation. It may be better in some cases to consider marketing these products as drugs or food supplements in the future.
Even for those who wish to reapply for CE certification for their existing medical devices, some confusion may result from the changes in regulation. In all these cases, it is a good idea to seek the help of experienced consultancies such as a&r in order to proceed with confidence.
Dr. Joerg Gruenwald is president of analyze & realize ag, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize ag, Waldseeweg 6, 13467 Berlin, Germany, Tel: 49-30-40008100; Fax: 49-30-40008500; E-mail: jgruenwald@analyze-realize.com; Website: www.analyze-realize.com.
Medical devices are explicitly intended to diagnose, prevent or treat diseases, allowing strong claims to be made, which makes them more attractive than food products, including supplements, from a marketing perspective. As Class I, Class IIa or Class IIb devices, they can, for example, be formulated as orally taken tablets or capsules; they can even be combined with pharmacologically active substances (Class III), as long as their main mode of action is physical rather than pharmacological. This makes their appearance virtually indistinguishable from food supplements to the consumer.
The demarcation between an oral medical device and a food supplement is a blurry one. For Class IIa, IIb and III medical devices, a Notified Body—the authority that grants the CE mark to a new medical device—will make a decision on whether the main action of the product is physical or pharmacological. Some Notified Bodies will judge this more harshly than others, which is why manufacturers often have their preferred Notified Bodies.
Change on the Horizon
Soon, however, all this is going to change. After all, in the 20 years since the Medical Device Directive was drawn up, the EU itself has changed, acquiring more member states and becoming more harmonized. More importantly, medical device technologies have advanced. Especially in implant technology, new safety issues have resulted in the necessity of revising the old directives. Thus, the Medical EU Directives will be replaced by the Medical Device Regulation, with far reaching consequences.
For one thing, all Notified Bodies will lose their status as such. In order to become a Notified Body in accordance with the new regulations, all organizations will have to re-apply. The new regulations will emphasize the clinical evaluation part of the certification process; Notified Bodies will have to employ qualified staff specialized in the areas of effect for the various medical devices that are submitted.
At the same time, all Declarations of Conformity previously granted according to the EU Medical Device Directive will become invalid. This means that all medical devices in use today, from latex gloves to implants to oral medical devices, will have to re-apply for their CE mark (with the newly re-authorized Notified Bodies). These applications will then be evaluated according to the new regulation, which may very well mean that many Class IIa, IIb or Class III medical devices that barely slipped past the device/drug demarcation will not receive a CE mark again, and thus not a marketing authorization as a medical device.
Of course, before all this comes into effect, a suitably long transition period is expected to be implemented, as the workload of merely re-certifying every medical device in the EU is going to be immense.
Conformity vs. China Export
While we are on the subject of the CE mark, here is an interesting fact. The CE mark is a mark of conformity that is used extensively in the EU to denote conformity with all sorts of regulations. Marks are found not only on medical devices, but also on all electric or electronic appliances, where they signal to consumers that the device in question has passed testing and therefore is safe to use.
The logo CE (China Export) looks almost exactly the same, down to the rounded shape of the E and the proportions of both letters. The only difference is that both letters are slightly closer together in the China Export logo than they are on the European Conformity logo. Both logos are so similar that you have to be aware of this difference in order to spot it.
The China Export logo, not surprisingly, is embossed on all products manufactured in China and exported into the EU, such as children’s toys, and of course, electronic devices. It does not denote conformity with any regulation, nor is it a symbol of safety. However, the end consumer can hardly fail to mistake it for just that, and to assume a safety of use that may not exist.
Moving Forward
With the revision of the medical device regulatory situation in Europe, it may be worth it for manufacturers to re-think their product strategy with oral medical devices. It seems likely that many former Class IIa, IIb and Class III medical devices may not be granted medical device status under the new regulation. It may be better in some cases to consider marketing these products as drugs or food supplements in the future.
Even for those who wish to reapply for CE certification for their existing medical devices, some confusion may result from the changes in regulation. In all these cases, it is a good idea to seek the help of experienced consultancies such as a&r in order to proceed with confidence.
Dr. Joerg Gruenwald is president of analyze & realize ag, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize ag, Waldseeweg 6, 13467 Berlin, Germany, Tel: 49-30-40008100; Fax: 49-30-40008500; E-mail: jgruenwald@analyze-realize.com; Website: www.analyze-realize.com.
