The term ‘medical device’ covers a vast range of products from scalpels and sticking plasters to spinal implants and heart valves and a wide variety of drug delivery devices such as prefilled syringes, auto-injectors, inhalers, and infusion pumps.
Smithers Rapra can support you with your medical device submission
In Europe, the main regulation is ‘Council Directive 93/42/EEC of 14 June 1993 concerning medical devices’ (the Medical Device Directive, MDD) and its amendments to date. Amongst the other requirements of the directive, there are certain physico-chemical requirements, described in Annexe 1 of the Directive, as follows;
- To ensure “the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the intended purpose of the device, ...”
- “The devices must be designed and manufactured in such a way that they can be used safely with the materials, substances and gases with which they enter into contact …”
- “… if the devices are intended to administer medicinal products they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned …”
- “The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device …”
The BS ISO 10993 series of standards ‘Biological evaluation of medical devices’ provide methods to assess/show biological compatibility and to characterise materials with particular reference to degradation products and their toxicity assessment.
Specifically, the chemical analysis facilities and experience available at Smithers Rapra enable us to undertake testing according to Parts 13 & 18 of ISO10993
- ISO 10993 Part 13: Identification and quantification of degradation products from polymeric medical devices;
- ISO 10993 Part 18: Chemical characterisation of materials.
Other assessments for compatibility with medicinal products and to identify toxicity risks from substances leaking and, using the World Health Organisation’s terminology, leaching from a medical device can be achieved by performing extractable and leachable studies.
For most devices an extractables study, to identify any potentially migrating substances, is relatively straightforward. However for an implantable device, e.g. a contact lens, a leachables study, to identify what migrates and how, is much more difficult to define/conduct. Therefore a simulated exposure experiment is conducted to assess the levels of those target substances that the patient might be exposed to.
Smithers Rapra can help devise a suitable study or programme of work to meet these needs.
Combination products, which may comprise both a medical device and an active pharmaceutical ingredient, can be complex from a regulatory point of view, with the FDA, the EMA and MHRA each taking different approaches and responsibilities. For a combination product in the EU, both the MDD and the medicines directive may apply.
Talk to Smithers Rapra to discuss the various testing options available.
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