Your CRO partner for successful management of clinical studies in Europe, US, Canada and Israel for medical devices, IVDs and combination products.
A trusted resource for US and EU medical device regulatory and quality system requirements also providing EU Authorized Representative and US Agent services.
In Vitro Diagnostics
In Vitro Diagnostics
IVDs have distinct requirements in both the US and Europe. We have the IVD regulatory, quality system and clinical study expertise needed for US and European market entry.
Helping companies understand the important differences between US and European requirements for drug-device combination products and drug delivery devices.
Shake-up ahead for devices in Europe?
19 September 2014
Medical device manufacturers in Europe and elsewhere will be affected by two news items that emerged from the European Commission and European Parliament this week.
Firstly, responsibility for medical devices (together with medicines and cosmetics) is set to change from the current Directorate General (DG) SANCO to the DG for the Internal Market, Industry, Entrepreneurship and SMEs, under newly-appointed Commissioner Elżbieta Bieńkowska, from Poland, under a move proposed by President-elect Jean-Claude Juncker. Although this would be a new 'home' for medicines, it would be a return to the 'Industry' DG for medical devices and cosmentics, which were transferred to DG SANCO only four years ago.
Many objections have already been raised against this proposal, which first has to be approved by the European Parliament (EP), notably by British MEP Glenis Willmott, of the Progressive Alliance of Socialists and Democrats, who has just been named as the Rapporteur responsible for taking over the reins of the new Medical Device Regulation from Dagmar Roth-Behrendt, overseeing the second reading in the EP, and negotiating with the Council of the EU and the European Commission on the final text. On her website, Ms. Willmott states:
“We must ensure the industry is transparent and works in the interest of patients. This legislation will go a long way to achieving that and I look forward to taking it further in the coming months.”
“I am concerned, however, with the proposals that medical devices should fall under the responsibility of the Industry Commissioner. Our first priority with these products must be health, and they should be overseen by the Health Commissioner. I will be doing everything I can to ensure that this is the case.”
Ms. Willmott is no stranger to health-related matters, having been Rapporteur for the recently enacted Clinical Trials Regulation.
FDA publishes Special Controls guidance for Tryptase Test Systems
17 September 2014
The US Food and Drug Administration (FDA) has issued a guideline titled, 'Class II Special Controls Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic Mastocytosis' in support of the down-classification of tryptase test systems into class II (special controls).
FDA explains that a tryptase test system is an in vitro diagnostic device that aids in the diagnosis of systemic mastocytosis, used as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.
This guideline "identifies measures that FDA believes will mitigate the risks to health associated with these devices and provide a reasonable assurance of safety and effectiveness". The guidance also notes that firms submitting a 510(k) for a tryptase test system must either:
Comply with the particular mitigation measures set out in the guideline, or
Use alternative mitigation measures to demonstrate to the Agency's satisfaction that they will provide at least an equivalent assurance of safety and effectiveness.