98/79/EC certification
In vitro diagnostic medical device 98/79/EC certification
If you want to enter European economic area with your product qualified as In vitro diagnostic medical device, CE marking is the only way how to proceed. The European parliament and council directive 98/79/EEC has been implemented in order to unify marketing rules over each member state in the meaning of single common market.
In vitro diagnostic medical device:
According to the European parliament and council directive 98/79/EC In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients, or
— to monitor therapeutic measures.
Examples of In vitro diagnostic medical device:
– HIV, HBsAg elisa tests
– ovulation and pregnancy tests
– blood sugar monitoring systems, strips
– blood group tests
Specimen receptacles are considered to be In vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimen derived from the human body for the purpose of in vitro diagnostic examination.
Products for general laboratory use are not In vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;
Accessory means an article which, by itself is not qualified as an In vitro diagnostic medical device, however is intended specifically by its manufacturer to be used together with an In vitro medical device to enable that device to be used in accordance with its intended purpose. However for the purposes of this definition, invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not be considered to be accessories to In vitro diagnostic medical devices;
Self-testing In vitro diagnostic medical devices: special group of devices intended to be used and results interpreted by lay person in home environment. For example devices for pregnancy or ovulation testing.
Device for performance evaluation means any device intended by its manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside his own premises.
Conformity assessment route
Module H – Full quality assurance
Manufacturer follows Annex IV (excluding section 4 and 6)
or
Module D – Production quality assurance
+
Module B – EC type examination
Manufacturer follow Annex VII (excluding section 5) and Annex V
or
Module F – Product verification
+
Module B – EC type examination
Manufacturer follow Annex VI and Annex V
or
Module A – EC design examination
Manufacturer follows Annex III section 6
Conformity assessment route
Module H – Full quality assurance
Manufacturer follows Annex IV (excluding section 4 and 6)
or
Module D – Production quality assurance
+
Module B – EC type examination
Manufacturer follow Annex VII (excluding section 5) and Annex V
or
Module F – Product verification
+
Module B – EC type examination
Manufacturer follow Annex VI and Annex V
Conformity assessment route
Module H – Full quality assurance
Manufacturer follows Annex IV
or
Module D – Production quality assurance
+
Module B – EC type examination
Manufacturer follow Annex VII and Annex V
Process of In vitro diagnostic medical device 98/79/EC certification and CE marking
CE marking process of In vitro diagnostic medical devices is evaluation of conformity with essential requirements laid down by the directive 98/79/EC. The basis for the evaluation by certification or if required by notified body is technical file. Technical files contain objective evidence, provided by the manufacturer of In vitro diagnostic medical device, in order to demonstrate compliance with applicable requirements.
Common format used and widely accepted is document GHTF/SG1/N063:2011 STED (Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices) issued by Study Group 1 of the Global Harmonization Task Force.
The most Essentials part of technical files are performance evaluation and risk management. Is expected the manufacture follows harmonized standard EN ISO 14971:2012 which determines basic principle of application risk management to medical device.
Performance evaluation represents the most critical part of the technical file as the main assessment aspect is to prove performance and safety of the In vitro diagnostic medical device under CE marking assessment. In addition in case of product stated in List A of annex II additional requirements laid down by specific Common technical specification (CTS) shall be followed and compliance with these specifications shall be proved by objective evidence.
Except the legally binding requirements there are issued guidelines like MEDDEV documents which are intended to describe common practice and guide manufacturers during CE marking process, despite the fact MEDDEV guidelines are not binding documents and manufacturer has a “free” choice to follow them is highly recommended to follow those guidelines as current state of art in certification processes. Certification or notified body will always assess you according to those documents and described requirements.
Manufacturers shall as well comply with the European regulation 722/2012 the use of materials of animal origin which requires manufacturers to utilize science-based processes to eliminate or inactivate TSE-infectious agents. However despite the all applicable directives related to the assessment and CE marking process of medical devices, there is wide range of other relevant documents, from MEDDEV, interpretative or consensus statements to European technical standards which shell be taken in consideration during the development of products and as well technical files or design dossiers.
What to expect?
Application review
- initial assessment of CE marking application, correctness of qualification and classification of the device intended to be CE mark
- review of company and product profile and determination of necessary assessment activities and required qualification of assessment team
Technical file assessment
- comprehensive challenge of technical files or design dossiers against the all applicable criteria and requirements
- opportunities for corrections and submission of additional proves of compliance
Initial audit
- on site assessment of quality management system against the standard EN ISO 13485 and additional directive 98/79/EC requirements
Certification decision
- certification or notified body decides, based on the all particular assessment results whether manufacturer and its In vitro diagnostic medical device meet all requirements and is possible to grant 98/79/EC certification according to the directive
Surveillance audit
- in case certification is granted annual surveillance audits are held. In case of high risk products is possible the frequency of surveillance audits is more frequent than once per year
Unannounced audit
- in addition to surveillance audits, audits without prior notification are performed in order to verify continuous compliance with CE marking requirements
Batch verification and batch release
- each manufactured batch of List A In vitro diagnostic medical device before market placing is intended to past verification by notified body and its approval for the batch release
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