Contribuiamo al successo delle aziende
di Dispositivi Medici e Diagnostici in Vitro
negli Stati Uniti ed in Europa
Potenziamento dei servizi negli Stati Uniti ed in Serbia!
Siamo lieti di annunciare la nomina della D.ssa Ana-Maria Panaitoiu a US Clinical Services Coordinator. Ana-Maria è un medico con esperienza ventennale di gestione e monitoraggio di studi clinici negli Stati Uniti e Canada. Il suo background clinico è principalmente nel settore cardiovascolare ed in oncologia, ma ha anche acquisito esperienze in molteplici aree terapeutiche avendo lavorato con dispositivi medici, IVD e medicinali. E parte del nostro gruppo dal 2014.
La nostra copertura geografica si espande ora anche alla Serbia dove abbiamo intrapreso una collaborazione con il Dr. Predrag Vasiljević, medico e senior clinical monitor con vasta esperienza in studi clinici con dispositivi medici condotti nei paesi dellest 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.
Final versions of EU MDR and IVDR now available
24 February 2017
The Council of the European Union has published final versions of the new European regulations on medical devices and in vitro diagnostic devices, together with summaries of the reasons for the substantial changes from the preceding medical device directives.
Now that the texts have been finalized, the European Council is scheduled to hold a vote to pass the regulations on 7 March 2017, followed by a vote in the European Parliament on 20 March 2017. If they pass, the regulations could be formally published in the Official Journal of the European Communities in May 2017, and enter into force in late May or early June 2017. If this timescale hold true, the Medical Device Regulation (MDR) would be fully applicable from May/June 2020, and the In Vitro Device Regulation (IVDR) regulations would two years later.
The new texts introduce major changes for all involved in the design, manufacture, supply, distribution and certification of medical devices in Europe, making the introduction of devices into the European market probably the most difficult in the world, potentially delaying the introduction of new devices into member states, and discouraging manufacturers from introducing new devices into Europe first, reversing a practice that has been generally accepted for the last 25 years.
Copies of the documents are available from the followijng links:
The European Court of Justice has passed judgment on the liability of PIP's Notified Body (NB), TÜV Rheinland, after considering NB responsibilities under the Medical Devices Directive (MDD, 93/42/EEC). A copy of the press release issued by the ECJ can be accessed here.
The judgment states that NBs do not have a general obligation "to carry out unannounced inspections, to examine devices and/or to examine the manufacturer’s business records under the Medical Device Directive."
The case that led to the referral to the EU Court was brought by a German citizen that had PIP implants fitted in Germany in 2008, and had them removed in 2012. She claimed that TÜV Rheinland was liable for damages, because it had not fulfilled its obligations satisfactorily, because she claimed: “an inspection of the delivery notes and invoices would have enabled TÜV Rheinland to ascertain that the manufacturer had not used an approved form of silicone.”
Her claims were rejected by the first and second instance courts in Germany, but the second instance court referred questions of law to the European Court concerning the scope of a notified body’s duties, “in particular with regard to the level of supervision and scrutiny required of that body when it carries out inspection visits at the manufacturer’s premises”, specifically in the context of a Class III device under MDD Annex II.
The Court found that while NBs must periodically undertake appropriate inspections and assessments under Annex II, but “the provisions of Annex II to Directive 93/42 do not impose a general obligation on the notified body to carry out unannounced inspections, to examine devices and/or to examine the manufacturer’s business records.”
While this judgment is undoubtedly helpful to TÜV Rheinland, it is not the end of the matter, as further cases are still to be heard in other European countries, where local product liability laws may be interpreted differently.
Articoli da European Medical Device Technology (EMDT)
Gli articoli più recenti scritti dalla D.ssa Maria Donawa e pubblicati dalla rivista European
Medical Device Technology possono essere scaricati qui.
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