Contribuiamo al successo delle aziende di Dispositivi Medici e Diagnostici in Vitro negli Stati Uniti ed in Europa
Siamo esperti riconosciuti nella gestione di studi clinici su Dispositivi Medici, IVD e Combination Products in Europa, Stati Uniti e Canada.
Da oltre 20 anni Donawa Lifescience Consulting (DLC) offre consulenza regolatoria specializzata
ed altamente qualificata nel settore dei Dispositivi Medici, inclusi i Combination Products
e gli ATMPs (Advanced-therapy medicinal products). DLC può
agire inoltre come mandatario europeo (Authorized Representative) per fabbricanti con sede legale extra europea.
Diagnostici in Vitro
Diagnostici in Vitro
Da oltre 20 anni Donawa Lifescience Consulting (DLC) offre consulenza regolatoria
specializzata ed altamente qualificata nel settore Dispositivi Medici,
inclusi i Diagnostici in Vitro (IVD). DLC può agire inoltre come
mandatario europeo (Authorized Representative) per fabbricanti con sede
legale extra europea.
Esistono molte differenze tra le normative europee e statunitensi sui
Combination Products e i dispositivi drug-delivery. Donawa Lifescience
Consulting ( DLC ) puo fornire consulenza strategica per identificare
tali differenze così da permettere il raggiungimento delle varie
tappe dello sviluppo del prodotto nel rispetto dei tempi previsti.
Commission releases MDR/IVDR corrigenda
22 March 2019
The eagerly-awaited corrigenda for the European Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746) have now been released by the European Commission.
To many in the industry, the revisions to the regulations will be disappointing, as they correct only typographic or other obvious errors in the original documents, without addressing any of the dozens of ambiguous requirements, which are already leading to different interpretations by manufacturers, notified bodies and competent authorities.
This result is despite the fact that the French competent authority ANSM published a report from a meeting with industry in which it went on the record saying that In addition to simple editorial corrections, it had been proposed to extend the transitional measures to Class I devices that newly require the use of a notified body or Class I devices that change class under the MDR, in order to avoid overloading NBs.
In the MDR corrigendum, there are 14 corrections, with some as simple as changing the word “trademark” to “trade mark” in Articles 2 and 7, or grammatical changes, while others, such as correction number 7, will mean that products of animal origins legally placed on the market prior to 26 May 2020 will not be allowed on the market after that transition date in such member states that previously allowed them.
The IVDR corrigendum, meanwhile, includes 17 corrections, with some minor tweaks that match the MDR changes, corrections of grammatical errors and others that may have more of an impact.
FDA finalises guidance on devices with animal-derived material
16 March 2019
The US Food and Drug Administration (FDA) on has finalised its guidance, drafted in 2014, for medical devices containing animal-derived materials.
The Agency states that the final guidance seeks to help industry address the risks of human pathogens that could contaminate animal material, and thus be present in a medical device that contains contaminated material derived from animal sources.
“The role of animal-derived material in medical devices is well established,” FDA’s Center for Devices and Radiological Health (CDRH) said on Thursday. “However, the use of animal materials introduces the risk of disease transmission from animals to humans.”
The 13-page final document builds on clarifications provided in the 2014 draft, at least in part due to concerns industry raised in submissions during the draft’s comment period. A concern with the drafted guidance led critics to urge CDRH to reference the ISO 22442:2007 series of standards, which addresses animal-derived tissue use.
“Used in concert with the ISO 22442 series of standards, this guidance is intended to help you identify the possible risks related to medical device components and/or manufacturing reagents that are sourced from animal tissues,” CDRH states in the final version.
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