Gruppo IMQ

MEDICAL DEVICES: IMQ AUTHORIZED AS A NOTIFIED BODY EVEN FOR ACTIVE IMPLANTABLE

IMQ, already authorized as a Notified Body to all procedures provided for in Medical Devices Directive, is now acknowledged even as a Notified Body for Medical Devices in class III and on active implantable medical devices (AIMD)


 

IMQ can now support enterprises manufacturing active implantable Medical Devices to place their products on the market.
Active implantable Medical Devices (AIMD) are, of course, high-tech risk products (e.g. pacemakers, cardiac pacemakers, hearing peacemakers, inhibitors, ...) designed to stay in direct physical contact with the human body for long periods, and therefore subject to strict standards and requirements to protect the health and safety of patients.


The Directive concerning their marketing is the 90/385/EEC, and it specifies both the essential requirements and other requirements to be met before placing on the market and/or placing into service the active implantable AIMD.


This Directive also sets out - for active implantable Medical Devices - the steps for conformity assessment procedures (certification schemes), recognizing both manufacturers’ and Notified Bodies’ mutual responsibilities.
To apply the CE Marking on AIMD devices and legally market them in EU countries, manufacturers and importers have to meet some Essential Requirements, that are as follows:
1. not to compromise the clinical condition or the safety of patients
2. not to pose any risk to people who implant them
3. to guarantee the performances by the manufacturer
4. to be so designed as to withstand storage and transportation conditions.
In order to certify that all requirements have been met before being placed on the market, AIMD devices shall be subject to an assessment procedure for conformity by a Notified Body, such as IMQ.
As a Notified Body for AIMD (Directive 90/385/EEC - Annex 2 and 5), IMQ technicians can support companies in the process for placing them on the market, in particular for:
• active implantable medical devices for stimulation/inhibition
• medical devices with reference to Directive 2006/42/EC on machinery
• devices which incorporate software, use software, and that are controlled by software
• medical devices in sterile packaging

 

Due to a long-term experience in this field and to the expertise of its own technicians, IMQ became a leading certification body in the field of medical devices. In general, IMQ can offer companies the following services:

• EC declaration of conformity with respect to the Full Quality Assurance System
• EC declaration of type conformity concerning Production Quality Assurance.
• Testing services under the Directive, including audit of the manufacturer's quality system.
• Review of project dossier and technical file, according to the requirements of the AIMD Directive and issue of the product certificate, after a positive outcome of the assessment.
• Quality Management System Certification
• Active implantable medical devices testing to be carried out at the customer's premises under the Body supervision.

IMQ can also support companies on the following activities:
• Testing and conformity assessment under the technical standards for electro-medical devices (standards of IEC/ISO 60601 series) and under collateral and relevant special standards.
• Testing and conformity assessment under the directive on Radio equipment and Telecommunication Terminal equipment (R&TTE Directive) and under the RED (Radio Equipment Directive).
• Radio products mainly used on electro-medical devices.
• Audit and certification according to the ISO13485 CMDCAS standards.
• Audit according to the MDSAP scheme.
• Support for the extra-EU records


“The extension of the IMQ notification also to active implantable” said Bernardino Venturelli of IMQ “allows us to give our full support to companies within the medical industry, that we have been assisting over the years, becoming more and more a business partner on that path of excellence characterizing them likewise worldwide.”

 

 

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