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.
FDA issues draft guidance on 'Feedback After Certain FDA Inspections'
16 February 2019
The US Food and Drug Administration (FDA) has issued a draft guidance titled 'Nonbinding Feedback After Certain FDA Inspections of Device Establishments', which proposes a method for medical device manufacturers to request nonbinding feedback from FDA in response to certain kinds of observations the FDA may document during an inspection of the device establishment that are issued on a Form 483 'Notice of Observations'. The guidance also outlines statutory criteria for being eligible for this feedback.
FDA explains that it believes timely, nonbinding feedback can help device manufacturers determine whether their proposed actions to address inspectional observations are adequate, possibly avoiding unnecessary investment on potential solutions unlikely to satisfactorily address an inspectional observation.
The draft covers:
Submitting a timely request for nonbinding feedback;
Statutory eligibility criteria for nonbinding feedback;
Justification of request;
Proposed responsive actions;
The FDA encourages industry and other stakeholders to review the draft guidance and to provide comments. The comment period will be open for 60 days in the Federal Register under docket number FDA-2018-D-4711, starting February 19, 2019.
'No-deal' Brexit threatens major disruption for medical device manufacturers
13 February 2019
UK-based Notified Bodies and Authorised Representatives provide a significant proportion of the services mandated before medical device manufacturers can place their products on the European market. Notified Bodies are needed for all but non-sterile, non-measuring, Class I devices; Authorised Representatives are required by all non-European manufacturers exporting devices to Europe. Of the four UK-based Notified Bodies, only one, BSI, has completed the establishment of a sister Notified Body within the EU-27, while some estimates place over 50% of all Authorised Representatives within the UK.
If there is a 'no-deal' Brexit, after 29 March 2019, device manufacturers who identify that they use a UK Notified Body or a UK Authorised Representative on their device labeling will not be allowed to place new devices on the EU-27 market, according to a European Commission 'Notice to Stakeholders' published in January 2018. This harsh reality is now echoed in the latest update to the post-no-deal information published by the UK Medicines and Healthcare products Regulatory Agency (MHRA), in which the Agency explains: "If there’s no deal, UK-based NBs will no longer be recognised by the EU after 29 March 2019, meaning the devices they have certified will no longer be in conformity with the applicable EU Directive. As such these products will not be able to be placed on the EU market".
Although the MHRA document is silent on the subject of Authorised Representatives, it is assumed that the same principle will apply, as outlined in the Commission's January 2018 Notice, which states: "Authorised representatives or responsible persons established in the United Kingdom will not, as from the withdrawal date, be recognised as authorised representatives or responsible persons for the purposes of the applicable Union product legislation. Therefore, manufacturers are advised to take the necessary steps to ensure that, as from the withdrawal date, their designated authorised representatives or responsible persons are established in the EU-27".
As the prospect of a 'no deal' Brexit seems more likely now than previously, it is probably already too late for manufacturers who are currently using non-BSI UK Notified Bodies to obtain CE marks for their devices with a new Notified Body within the EU-27. The situation for non-European manufacturers with a UK Authorised Representative is not so problematic, however, as a change in Authorised Representative designation can generally be made relatively quickly, although the timescale for revising device labeling must be taken into account. In addition, UK-based device manufacturers will have to appoint an EU-27 Authorised Representative after 29 March 2019, in the event of no deal.
Donawa Lifescience Consulting, being based in Rome, Italy, is able to offer non-European and UK manufacturers an EU-27 Authorised Representative service with a rapid turnround, should a 'no-deal' Brexit come to pass.
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