European Medical devices Act


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Emma Neri
30th October 2012

Scope of regulations
The first novelty concerns the scope of the legislation, which has been expanded and now includes the tissues and cells substantially manipulated, plus other implantable or invasive products without medical purposes, similar to medical devices that are not covered by ATMP legislation (Advanced Therapy Medicinal Products). This includes products such as pre-filled syringes of human collagen and implants for aesthetic purposes. Is this positive?

"There is no good scientific definition of the concept of 'substantially manipulated' within the ATMP or the proposed new regulation of medical devices (MDR), so that if a Member State not fully understand a particular device will tend to think it is dangerous and apply the strictest standards, "says Vollebregt.

Another interesting aspect is wider that includes anything that 'helps' the operation of a medical device. "This will particularly affect eHealth and the entire software industry, " said Vollebregt.

Accreditation and monitoring of Notified Bodies
The proposal also sets stricter conditions for accreditation and monitoring of Notified Bodies, but Vollebregt has already detected some problems. "An important requirement that has been introduced is the control of outsourced audit quality, " says Vollebregt. "Notified Bodies also have the right and duty to carry out inspections at factories without notice and physical testing laboratory or devices. The legislation attempts to turn the Notified Bodies in a kind of police inspectors, but does not provide the necessary tools to be able to act effectively. "

Screening procedures could delay market access

One of the biggest changes is the addition of a new screening procedure the procedure of conformity assessment, a measure on which Eucomed has expressed great concern. This creates a 'Coordination Group medical devices' (MDCG) that will evaluate and make recommendations to the Notified Bodies for the certification of Class III devices, but according to industry representatives, this will delay the market access and improve safety the patient.

"Until now, one of the competitive advantages of the EU was that medical technology could access markets quickly, " says Vollebregt. "Now MDCG a manufacturer may require years of clinical trials for something they consider interesting, even if based on outdated science, and the manufacturer shall have no legal recourse."

Stricter conditions for clinical research
"The Commission tried to copy the 2001 version of the Clinical Trials Directive, which is based on the 1996 standards of the ICH (International Conference on Harmonization of Technical Requirements) "says Vollebregt, " yet the Global Harmonization Task Force (agency for the global organization) has advanced the ideas about medical device clinical research. This means that the Commission is pushing back the standards of clinical trials of devices. "
The rules require that each step of the supply chain verify that the step satisfies the conditions. It will introduce a new EU portal in which manufacturers must report serious incidents and take corrective action to prevent recurrence.

Directory of the European Medical Device & Biomaterials Industry
Book (Elsevier Science Pub Co)
2006-04-15 20:34:56 by merrimac

No it doesn't there is accurate non Lab versions

Cholestech LDX System, which carries the CE Mark for marketing of medical devices in the European Union, has been certified
by the United States Cholesterol Reference Method Laboratory Network (CRMLN), which validates that the system meets the gold standard for accuracy and reproducibility developed by the Centers for Disease Control and Prevention (CDC) for the measurement of total cholesterol and HDL cholesterol consistent with National Cholesterol Education Program (NCEP) analytical goals. The NCEP recommends that everyone over the age of 20, or more than 200 million Americans, should be screened for cholesterol.

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