Medical Devices and IVDs
How InViva can help with MD and IVDs??
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- Technical File
Medical device directives require the manufacturer of the product to create a technical file containing the information required to show that the product complies with the requirements of the directives for CE Marking.
Whilst the directives contain general details of the sort of information which will be required in the technical file, this information is general and high level / non prescriptive. Typically, the following minimum items should be included:
- Design specifications / Design File
- Description of the apparatus, usually accompanied by block diagram
– Wiring and circuit diagrams
– General Arrangement drawing
– List of standards applied
– Records of risk assessments and assessments to standards
– Description of control philosophy/logic
– Datasheets for critical sub-assemblies
– Part list
– Copies of any markings and labels
– Copy of instructions (user, maintenance, installation)
– Test reports
– Quality control & commissioning procedures
– Declaration of Conformity
Additional information may include copies of the engineering drawings for any bespoke parts. However, this additional information should not be used to pack the file at the expense of the more relevant information on how the equipment operates and how it meets the safety objectives of the Directives.
It should be noted that simple products will require less information in the corresponding technical file as opposed to more complex or medical devices.
The CE mark is required for a product in order to:
show that the manufacturer has checked that the product meet EU safety, health or environmental requirements
provide an indicator of a product’s compliance with EU legislation
allow the free movement of products within the European market
The inclusion of the CE mark on a product represents the manufacturer’s declaration, on their sole responsibility, that the product conforms with all of the legal requirements to achieve CE marking. The manufacturer is thus ensuring validity for that product to be sold throughout the EEA. This also applies to products made in third countries which are sold in the EEA and Turkey.
Not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked. A CE Mark must be applicable to all Medical Devices and Medical Products
A CE mark is not intended to denote that a product was made in the EEA, but states that the product is assessed before being placed on the market in the EEA. It means the product satisfies the legislative (safety and efficacy) requirements to be sold in the EEA and that the manufacturer has checked that the product complies with all relevant essential requirements, for example health and safety requirements.
Manufacturers are responsible for ensuring they:
carry out the conformity assessment
set up the technical file
issue the EC Declaration of Conformity (DoC)
place CE marking on a product
Distributors of Medical Devices must check the presence of both the CE marking and the necessary supporting documentation and ensure that the manufacturing site (particularly if it is outside the EU) has undertaken the necessary steps to comply with the CE requirements.
ISO 13485 details and specifies the requirements for a quality management system (QMS) by which an Applicant must demonstrate its ability to provide medical devices and related services that consistently meet regulatory requirements applicable to medical devices and related services. In particular, robust procedures for product safety updates and product recalls must be provided.
The primary objective of ISO 13485 is to facilitate harmonised medical device regulatory requirements for quality management systems. The requirements of ISO 13485 are not identical to ISO 9001 therefore Applicants with a QMS that is compliant to ISO 13485 cannot claim compliance to ISO 9001 unless their QMS has been separately certified to ISO 9001.
All of the requirements of ISO 13485 are specific and applicable to organisations providing medical devices, regardless of the type or size of the organisation.
If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organisation to ensure that claims of conformity with ISO 13485 reflect exclusion of design and development controls.