We dedicate this July issue to the current situation regarding the insufficient number of certified Notified Bodies under the new Medical Device Regulation (MDR). Also, recent innovations from traditional foods from third countries will be discussed.


Regulatory News

Are Notified Bodies (NB) the bottleneck for the industry under the new MDR?

The new Medical Devices Regulation (EU) 2017/745 (MDR) entered into force in May 2017, replacing the old Medical Decide Directive (MDD; 93/42/EEC medical devices). For a time period of 3 years following the entry into force of the MDR, manufacturers can decide to certify their products either under the new MDR or under the old MDD. However, after May 2020, this will no longer be possible. All medical devices require new certification by a Notified Body (NB). Nonetheless, NBs can only certify for the MDR after they have been designated for it.

Currently, and less than a year to go, only 2 NBs are designated to certify Medical Devices (MDs) under the new MDR out of the 59 NBs available in Europe for the old regulation. These NBs are TÜV Süd (Germany) and, ironically, the British BSI Group (UK).

Meanwhile, a few more NBs are expected to obtain approval under the MDR. The Commission strives to maintain an up-to-date list of Bodies notified by EU countries and make the necessary information available to all interested parties. Lists of Notified Bodies can be found on the NANDO website. However, we are not sure how many will be open for the so-called “substance-based“ MD certification under MDR. We expect a bottleneck for the certification of “substance based” MD products, as the reduced number of designated Notified Bodies may not be able to serve all requests. We are aware of some cases were NBs already provided negative feedback to clients wishing to pursue a MD certification for their products.

Presently, there is no official change on MDR implementation timelines and transition periods. Companies producing MDs are expected to encounter a great deal of problems to put their products on the market under the new MDR before May 2020. So, if you do not yet have a NB willing to take your dossier, problems might arise. Our team of experts can however support you with the dossier. Please contact us for more information.

Innovation Corner

Novel Food as a driver for innovation

Under EU regulations, any food that was not consumed “significantly” prior to May 15, 1997 is considered to be a Novel Food (EU) 2015/2283) and requires a pre-market authorization. According to the Novel Food Regulation, two types of applications – for “typical” Novel Foods (Article 10) and for traditional foods from third countries (non-EU) (Article 14) are possible.

As with other Novel Foods, traditional foods from a third country can only be placed on the EU market when the European Commission has adopted an implementing regulation authorizing the placing on the market of the traditional food. The notification for the placing on the market of a traditional food from a third country is sent to the Commission, who forwards it to all the Member States and EFSA. If there are no objections, the traditional food will be authorized by the EC for the EU market. In case a Member State or EFSA submits reasoned safety objections, the notification can be transformed into an application (Article 16).

To prepare the required technical dossier, it is advisable for applicants to follow the EFSA guidance for the preparation and presentation of notifications for traditional foods from third countries. This guidance aims to assist applicants with the preparation of a well-structured notification dossiers pursuant to Article 14 and applications concerning the data on the history of safe use in a third country pursuant to Article 16 of Regulation (EU) 2015/2283. Under this type of notification, food produced by primary production (e.g. harvesting, fishing, or hunting etc.) with a continued, traditional use over a period of 25 years in at least one country outside the EU may obtain marketing permission based on a notification procedure according to Article 14 of Regulation (EU) 2015/2283. In that case, the safety of the respective foodstuffs results from the proven history of safe use. The safety of a traditional food should be substantiated by reliable data on its composition, its experience of continued use, and its proposed conditions of use in the third country. The specifications of the traditional food and intended conditions of use in the EU must also be provided. If the formal requirements are met, it will take about 1 year from submission to authorization.

This notification procedure opens great opportunities for food business operators such as processors of exotic fruits and vegetables or traditional foodstuffs from countries outside the EU. Recent examples of notifications for traditional food from third countries currently under evaluation are cacao fruit pulp (Theobroma cacao L) by Cabosse Naturlas NV and cocoa pulp, and of products thereof by Nestec York Ltd. These notifications (although still pending for the EU market) come in line with recent innovative developments e.g. by Nestlé. The Swiss company announced this month that it has created a unique chocolate made entirely from cocoa fruit, using beans and pulp as the only ingredients and therefore not adding any refined sugar. This innovative chocolate formulation is planned to be launched in Japan in autumn.

If you would like to speak to our Novel Food experts get in touch. Our team can support you in the development of innovative solutions.

Upcoming events

Meet us at Vitafoods Asia!

Vitafoods Asia is the No. 1 nutraceutical trade show in Asia, bringing together science, business, and government agencies. If you are planning to be in Singapore between the 25th and 26th of September, meet our team of experts at booth P18 during Vitafoods Asia.

Let us be your eyes and ears! Do you need inspiration, to find partners, scouting, product ideas, ingredients supply?
Get in touch – we can support you!

Our team is passionate about the power of natural health products and wants to bring our expertise, enthusiasm, and creativity to help you deliver tailor-made innovation solutions that stand out from the market.

Book an appointment with us!

Also, do not miss our expert presentation during the show! Matthias Miller, our Managing Director, will be discussing the recent developments in the weight management category.

Life Stage Block: Adult Health
Date: Wednesday 25 September
Time: 14:20 – 14:50
Location: Life Stages Theatre, Stand G50

Our team of experts is looking forward to meeting you in Singapore.

NutraBusiness Intel

Sanofi and Google to develop new healthcare Innovation Lab

18 June 2019

Sanofi and Google are establishing a new virtual Innovation Lab with the ambition to deeply transform how future medicines and health services are delivered by tapping into the power of emerging data technologies. The Innovation Lab will develop both scientific and commercial solutions. The aim is to change how Sanofi develops new treatments and will focus on three key objectives: to better understand patients and diseases, to increase Sanofi’s operational efficiency, and to improve the experience of Sanofi’s patients and customers. Sanofi and Google also plan to apply artificial intelligence (AI) across diverse datasets to better forecast sales and inform marketing and supply chain efforts.


Reig Jofre acquires Bioibérica’s portfolio of finished pharmaceutical and nutraceutical products for joint health and pain

1 July 2019

Reig Jofre, a pharmaceutical company listed on the Spanish stock market, acquired Bioibérica’s specialized portfolio in joint health of finished pharmaceutical and nutraceutical products for the treatment of osteoarthritis and other arteriopathies and expands its product portfolio with drugs and health products based on chondroitin sulfate, glucosamine sulfate, the combination of both, and hyaluronic acid. The two Spanish companies have also entered into a strategic agreement to develop the joint health market.


BioGaia has signed an agreement with Abbott LatAmDermapharm takes majority stake in fitvia

2 July 2019

BioGaia, a Swedish healthcare company in the field of dietary supplements with probiotics, has signed an agreement with Abbott LatAm for the exclusive rights to sell BioGaia products under the BioGaia brand in Uruguay. BioGaia primarily focuses on pediatrics, gut health and oral health and the probiotic products are available in more than 100 countries. The launch is planned for 2020.


Nestlé invests in new open blockchain pilot program

2 July 2019

Nestlé has announced a pilot open blockchain technology in collaboration with OpenSC. OpenSC is a new blockchain-enabled food tracking platform developed in partnership between WWF-Australia and BCG Digital Ventures that allows consumers to track their food right back to the farm. This initiative will break new ground in supply chain transparency. The initial pilot program will trace milk from farms and producers in New Zealand to Nestlé factories and warehouses in the Middle East. Later, the technology will be tested using palm oil sourced in the Americas. These pilots will allow Nestlé to understand how scalable the system is.


Kaneka launches a takeover bid for 100% of AB-Biotics

10 July 2019

AB-Biotics announced this month that Kaneka Europe Holding Company has launched a voluntary takeover bid for 100% of the share capital of the company. The Japanese company is currently the biggest shareholder in AB-Biotics, owning 39.76% of its capital (by June). The takeover is voluntary and is expected to be amicable.


Novelties in our MatchMaking Platform

Now is the right time to start looking for a new product for cough & cold for your product portfolio. And we just added a new exciting licensing opportunity to our MatchMaking Platform! ID#94 is a well-established use product for productive cough that is available in an innovative and convenient dosage form, an orodispersible thin film.

To learn more about this business opportunity, contact our MatchMaking expert at matchmaking@a-r.com.


ID#102 is a clinically validated food supplement for prostate health support. It is an innovative and patented alternative to products with saw palmetto.

To learn more about this business opportunity, contact our MatchMaking expert at matchmaking@a-r.com.

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Your experts

Irene Wohlfahrt
Irene WohlfahrtSenior Consultant
Dr. Inês Rocha
Dr. Inês RochaScientific Consultant

At analyze & realize, we are experts in the field of natural health products, having provided our services for more than 20 years. We offer a unique combination of expertise in natural health products through our scientific, regulatory, and strategic innovation consulting and our clinical research organization with its own clinical trial center in Berlin, Germany. Thanks to our close interaction with the natural product market as well as our extensive network, we are always at the forefront of the latest information and innovation trends. With its international team of 35 employees, a&r is a leading European one-stop-shop ready to guide and support your needs in natural health product innovation.

Don’t hesitate to contact us: newsletter@a-r.com