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Shock for manufacturer of substance-based medical devices

Long awaited, widely feared and stunningly received: The newly published MDCG document 2022-05 poses already suspected and yet very considerable challenges to medical device manufacturers of substance-based medical devices. While the Medical Device Regulation (MDR) 2017 still supported and thus legitimised this type of medical device with the official designation of “substances and combinations of
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GMP Guideline, Annex 21

Annex 21 GMP Guideline (“Importation of medicinal products”) – what goes around comes around?   As of 16.02.2022, Annex 21 “Importation of medicinal products” of Volume 4 of the EU GMP Guidelines has finally been published. It will enter into force as a new Annex on August 21, 2022, i.e. 6 months after publication, and
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New timelines for IVD in Europe

Immediately effective prolongation of timelines for implementation of Regulation (EU)2017/746   The pandemic has a tight grip on the world. The healthcare authorities and institutions further suffer from the additional workload. The planned implementation of Regulation (EU) 2017/746 regarding in vitro diagnostic medical devices (IVDR) comes to the worst possible point of time. With the
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Systems and procedure packs

How to pack medical packages Both the MDD 92/43/EEC and the MDR 2017/745 allow packages of different products that are combined in a meaningful context for a specific intended use to be placed on the market. According to the MDD, these must be CE-marked products. The MDR also allows non-CE marked devices if their presence
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More time to be ready for IVDR?

About 90 % of all in vitro diagnostic (IVD) manufacturer cannot benefit from transition period laid down in Article 110 of Regulation (EU) 2017/746 (IVDR) and must be ready for IVDR in May 2022. The new Regulation will replace the current Directive 98/79/EC on in vitro diagnostic medical devices from 26 May 2022. The main
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Drug-Device-Combinations acc. to article 117 MDR

With the entry into force of the Medical Devices Regulation (EU) 2017/745 (MDR) at the end of May 2021, there have not only been many new and mostly more complex requirements for manufacturers of medical devices. Article 117 MDR also amends Annex I of the Medicinal Products Directive 2001/83/EC on so-called drug-device combinations to the
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Medicinal product or medical device? – Webinar

 March 30, 2021, 3 pm cet     In which category does my product belong? This is often a non-trivial question.   In theory, medicinal products and medical devices can be very appropriately distinguished in terms of their modes of action and thus their medical purposes: while medicinal products exert their effect in a pharmacological,
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Brexit Pharma

Brexit // Where do we go from here?

A cautious agreement has been reached for the future relationship between the European Union and Great Britain. Here are some facts about the given Brexit scenario regarding the pharmaceutical and pharmacy sector: The agreement contains specific provisions for both the pharmaceutical and pharmacy sectors, which are not as comprehensive as hoped: There will be separate
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Biocompatibility: No plan – no report!

  Among all the hurdles that the legislator has set up before medical devices can enter the market, the proof of biocompatibility poses particular challenges. Specialized service laboratories have an impressive number of corresponding tests in their repertoire: But which of these does your medical device really need?   In principle, the answer to this
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New efficacy test for veterinary disinfectants

Laboratorio Control, a reference partner of numerous companies for the analysis of biocidal products, implements a new efficacy test for disinfectants used on the skin in the veterinary industry.   > NEW PHASE 2,2 SKIN TEST FOR VETERINARY INDUSTRY (PT3). PR standard NF EN 17422:2019. The launch of this new quantitative surface efficacy test focuses
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In which foods are furan and its methyl analogs present?

In a recent recommendation, the European Commission calls for the determination of furan and methylfurans. These are process contaminants that form in food during thermal treatment. Consumers ingest furan particularly through coffee and cereal-based foods, but young children are also exposed to furan through jarred or canned ready-to-eat foods. According to the European Food Safety
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Laboratorio Control expands ENAC scope in food and animal feed

Laboratorio Control continues with its work plan focused on offering a wide range of analytical services under ENAC accreditation.   On this occasion, Laboratorio Control expands the ENAC scope in food and feed with the accreditation of mould and yeast count by culture according to ISO 21527-1 and 21527-2. Moulds and yeasts are one of
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Adalimumab – blockbuster & never ending story

Resolved patent disputes With Abbvie and Alvotech having solved their patent disputes, market entry for new biosimilars for adalimumab applicable for various indications might speed up. The patent protection of the originator product  Humira ® has expired in the EU in 2017, though due to complex patent claim development and market launch of non-component material
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Available NOW: Metals speciation for Inorganic Arsenic

There are two different forms of arsenic: organic and inorganic- and Columbia Labs tests for both. Inorganic arsenic is highly toxic and is therefore a public health concern; the organic form (commonly found in fish and seafood) is less harmful. The main source of exposure to inorganic arsenic is food; particularly grain-based processed products such
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Updated Analysis: Allergen Testing: More Savings, More flexibility

Allergen testing at Columbia Labs just got more affordable. Columbia Laboratories now offers allergen testing as either qualitative or quantitative, to cut costs and encourage routine monitoring. Allergens infiltrate the food supply at several control points, so routine testing of products AND their environment is KEY to keeping them out of your product line. Allergens
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Infusion from coffee leaves – Authorization as novel food

On occasion of the current discussions in DIN Tea, we would like to inform about “coffee leaf tea”. In addition to coffee cherry pulp (see News from 02-2022), the European Union has authorized an infusion from coffee leaves as a novel food (traditional food from a third country) in the EU. This product can already
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Laboratorio Kudam obtains Norovirus and Hepatitis A analyses accreditation

Laboratorio Kudam obtains ENAC accreditation for Norovirus and Hepatitis A testing in certain foods and bottled water. Tests are performed using the real-time PCR technique. Laboratorio Kudam continues its commitment to quality and the continuous improvement of all its analytical services and has therefore extended its ENAC accreditation for the following microbiological tests in food
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New Management at bilacon GmbH

For more than 30 years, bilacon has been supporting customers in the field of food, feed, food supplements and cosmetics with an extensive, accredited analytical spectrum. bilacon combines the competences of sensory, instrumental, chemical-physical, and microbiological analysis under one roof and answers all questions concerning the safety of your products. In April 2022, the management
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Fumigants – a more curse than a blessing? Are there alternatives?

The use of ethylene oxide in cereal products and spices repeatedly leads to massive recalls in the international trade. Due to the strict requirements regarding phytosanitary import controls, fumigants are currently the only effective alternative to prevent the introduction and spread of pests from importing countries. Thus, fumigation of containers for shipment, as well as
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