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.
ECJ rules in favour of TÜV Rheinland in PIP case
20 February 2017
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.
Implantable and Class III devices must share additional information with ANSM
9 February 2017
A revision to the French medical device law requires manufacturers of implantable and class III medical devices to submit a Summary of Product Characteristics to ANSM for all new devices introduced after 1 July 2017.
ANSM have introduced Décret n° 2016-1716 du 13 décembre 2016 under the auspices of Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015, laying down a ‘procedure for the provision of information in the field of technical regulations and of rules on Information Society services’.
This Directive allows member states to introduce new technical regulations “only where they are necessary in order to meet essential requirements and have an objective in the public interest of which they constitute the main guarantee”, and the Commission and other member states have been advised and “be allowed sufficient time in which to propose amendments to an envisaged measure, in order to remove or reduce any barriers which it might create to the free movement of goods.”
It is unclear whether this consultancy procedure has been completed and the new requirement advised to and agreed by the Commission and other member states. The MHRA was reportedly unaware of the new law, although ANSM states that the Commission was informed of the draft decree on 21 July 2016. MedTec Europe is understood to have raised the issue with the Commission in an attempt to delay introduction of the law until the Medical Device Regulation (MDR) takes effect, because it requires a similar summary, the Summary of Safety and Clinical Performance, to be publicly available.
Full details of the 14 specific data requirements can be found in the French law.
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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