From design to marketing, one of the crucial stages in the creation of an innovative medical device is making sure that it complies with standards and regulations.
Regulation (EU) 2017/745 and Regulation (EU) 2017/746 are the reference points specifying that the difference with a medication is the mode of action, which is physical for medical devices: electrical conduction, mechanical stimulation, thermal activity, etc. The regulations provide that these devices must comply with specific and detailed essential requirements. Therefore, they need to undergo numerous safety and efficacy tests in compliance with the strict protocols of the international (ISO), European (EN) and national (UN) technical reference standards and also classification tests in line with the new European regulation on medical devices.
Medical device means “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.”
The Italian laws transposing the European Community Directives divide medical devices into three different categories:
In addition, medical devices are divided into 4 classes, from the least critical to the most critical, as described in Annex IX of Italian Legislative Decree 24 February 1997, No. 46: I, IIa, IIb, III.
The classification depends on the complexity of the medical device and the potential risk for the patient on the basis of three factors:
On the basis of this classification, medical devices have to follow very different procedures to obtain conformity (CE marking):
The Regulation introduced the concept of ‘devices composed of substances‘. Their classification is defined on the basis of the new Rule 21 (Annex VIII).
What does Rule 21 envisage?
The devices composed of substances or of combination of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as:
Abich – Lifeanalytics, the Group’s Competence Center for Pharma and Cosmetic industries, will be your one-stop shop and will support you in all the necessary stages of your medical device, from research and development to market release.
Our services include:
Browse the full range of services in our website:
Compatibility test for use with condoms according to proprietary method based on ISO 4074
The test is designed to be applied to vaginal products and lubrificants with the purpose of substantiating the claim “Compatible with latex condoms”.
The test evaluates the compatibility of the product with latex, polyurethane or polyisoprene condoms analyzing any variation in the mechanical resistance to traction and bursting following contact with the lubricating medical device being analyzed in comparison with appropriate controls.
Biocompatibility test according to ISO 10993-10
The test is designed to be applied to finished products, textiles, solid products by eluate with the purpose of substantiating the claim “biocompatible”.
Biocompatibility test: triple analysis for irritation, cytotoxicity and sensitization potential.
Challenge Test according to ISO 11930 for cosmetics and European Pharmacopoeia for medical devices
The test is designed to be applied to cosmetics and medical devices with the purpose of substantiating the claim “Efficacy of preservatives”.
Challenge test for the evaluation of the efficacy of preservative systems according to ISO guidelines (for cosmetics) and European Pharmacopoeia (for medical devices).
At the customer’s request, further additional viruses can be tested.
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