About Emilie-Marie Vieuble

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So far Emilie-Marie Vieuble has created 121 blog entries.

Act now and get the most of it! Keep your substance-based medical devices in your portfolio with the support of analyze & realize

Background – What changed from MDD to MDR? What are the main implications for substance-based medical devices? In May 2017, the Medical Device Regulation (EU) 2017/745 (MDR) entered into force, replacing the old Medical Decide Directive (MDD; 93/42/EEC medical devices). So theoretically, for a time period of 3 years following the entry into force [...]

Act now and get the most of it! Keep your substance-based medical devices in your portfolio with the support of analyze & realize2019-09-03T10:26:06+02:00

Meet us at Vitafoods Asia!

Let's meet at Vitafoods Asia – Booth P18! 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. [...]

Meet us at Vitafoods Asia!2019-08-20T10:15:42+02:00

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) [...]

Novel Food as a driver for innovation2019-08-06T10:06:29+02:00

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 [...]

Are Notified Bodies (NB) the bottleneck for the industry under the new MDR?2019-08-05T11:54:43+02:00

NEWS DIGEST by a&r | July 2019

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. […]

NEWS DIGEST by a&r | July 20192019-08-01T10:28:03+02:00

EFSA considers Chia seeds powders as safe

The EFSA Panel on Nutrition, Novel foods and Food Allergens (NDA) just published a scientific opinion on chia seeds (Salvia hispanica L.) powders as novel foods (NFs) pursuant to Regulation (EU) 2015/2283. According to the EFSA panel, the partially defatted powders of whole chia seeds are considered safe under the assessed conditions of use. [...]

EFSA considers Chia seeds powders as safe2019-06-26T15:31:14+02:00

EFSA dedicated support for small and medium-sized enterprises (SMEs)

EFSA will extend their dedicated services to applicants from small and medium-sized enterprises (SMEs). SMEs will now be able to access support from EFSA when preparing, submitting, and monitoring their applications for regulated products. EFSA will use the experience gained in providing these new forms of support to decide whether to include them in [...]

EFSA dedicated support for small and medium-sized enterprises (SMEs)2019-06-05T12:43:53+02:00

a&r at Vitafoods Europe 2019

Vitafoods Europe is the perfect place to learn what is happening in the nutraceutical market. The show offers an excellent opportunity to engage in in-depth conversations with clients about opportunities in natural health products innovation. We hope you were able to find some time to stop by our booth and meet the team. We [...]

a&r at Vitafoods Europe 20192019-06-05T10:47:09+02:00