List of Applicable standard (LOAS)/Quality Standard
LOAS is a document that provides requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for purpose or intended use.
Before selling a medical device in the EU, manufacturers can make sure that the device complies with the requirement of EU regulation.
It is important to determine the following as soon as possible before the development of the device as they will help to identify which standards are applicable
- Intended use/Intended purpose of the device
- User population
- The target countries for selling device
- The environment where the device will be used
How to identify which standards are applicable to your device?
Identification of applicable standards to a particular medical device can be tedious as there is no “one-stop shop” to search.
- The Harmonized standard is a good place to start and they are applicable to a wide range of medical devices, as per EU-MDR, Article 8 devices that are in conformity with the relevant harmonized standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.
For e.g. EN 1041:2008: Information supplied by the manufacturer of medical devices
EN 556-1:2001: Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices EN 556-1:2001/AC:2006.
- The semi harmonized standard or another safety standard may be considered the next step to identify the product-specific standard.
For e.g. ISO 10993 (Biological evaluation of medical device) is series of semi-harmonized standards applicable to medical devices that come into direct or indirect contact with the human body. ISO 10993-1 guides you on how to conduct a risk-based assessment of the device based on the material components, the manufacturing processes, time of exposure, duration of contact, and the intended use of the device.
- Then you can identify product-specific standards, either in the Official Journal of the European Union or International Organization for Standardization (ISO) or ASTM or other databases.
- At last, you may add applicable guidelines as per your device.
- And if the medical device are manufactured with a new technology/ or having a new feature, standards may or may not exist or may be in draft form. So if the standard is not published yet it may be reliable to inform the relevant Regulatory Authority to determine the approach to conforming to the standard as it will not yet be known whether the Regulatory Authority will recognize the standard.
- Once you have identified which standards are applicable to your device, it is very important to check versions of standards that are recognized by each target country, whether they recognize an international standard in full or have their own national version, and whether the standard is considered voluntary or mandatory.