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 exempts 71 Class I devices from premarket notification
13 April 2017
The US Food and Drug Administration (FDA) has given notice in the Federal Register that it is exempting 71 types of Class I medical device from the need to file a premarket notification (510(k)) submission, subject to certain limitations.
FDA believes that the device types identified in the Federal Register list are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. This action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation.
A copy of the exempted device list can be obtained here.
Anomalies still exist in final MDR text - clinical investigation requirements
6 April 2017
Although having been reviewed by members of the Commission, Council, ENVI, Legal Services and Parliament, some anomalies still exist in the 'final' texts of the new European Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
Such an anomaly concerns two paragraphs in Article 61 on clinical evaluation in the MDR. Paragraph 4 sets out the conditions for avoiding the need to conduct clinical investigations and is applicable to implantable and class III devices. Briefly, the conditions are:
the device has been designed by modification of a device already marketed by the same manufacturer
the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, and
the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements.
Paragraph 5 sets out the conditions for avoiding the need to conduct a clinical investigation when two different manufacturers are involved, namely, a manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by him. Briefly, the conditions are:
the need to fulfill the conditions of paragraph 4
the two manufacturers must have a contract in place that explicitly allows the manufacturer of the device in question full access to the technical documentation of the device already on the market on an ongoing basis (first indent of paragraph 5), and
the original clinical evaluation was performed in compliance with the requirements of the MDR (second indent of paragraph 5)
Some readers are not considering the need to fulfill the conditions of paragraph 4 and are only considering the conditions listed in the first and second indents of paragraph 5. Based on this interpretation, paragraph would apply to all types and classes of devices. However, it is difficult to understand how the conditions in paragraph 4 can be met unless paragraph 5 applies only to a manufacturer that has designed a device by modifying a device already on the market by another manufacturer. Thus, with this latter interpretation, paragraph 5 applies only to modified devices.
In addition, some have assumed that paragraph 5 is limited to manufacturers of implantable and class III devices. However, this interpretation is not consistent with the manner in which regulatory provisions are written, including that of the MDR. That is, whenever a paragraph or section of the MDR applies to a certain type of device, that type of device is specified or a reference is provided to a paragraph or subparagraph that identifies the certain type of device to which the regulatory requirement applies. Paragraph 5 has no such specification or reference and thus, as written, appears to apply to all types and classes of device that have been designed by modification of a device already on the market.
It would be hoped that the text in paragraph 5 will be clarified before the MDR is published in the Official Journal. If this does not occur, competent authorities and notified bodies will need to adopt a consistent interpretation of these requirements to avoid inconsistencies in regulatory expectations.
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