93/42/EEC certification
Medical device 93/42/EEC certification
If you want to enter European economic area with your product qualified as medical device, CE marking is the only way how to proceed. The European parliament and council directive 93/42/EEC has been implemented in order to unify marketing rules over each member state in the meaning of single common market.
Medical device:
Medical device under meaning of the directive 93/42/EEC means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
Intended principal action in or on the human body of such medical device must be achieved pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
Classification of medical devices?
According to the current legislation there is followed classification of medical device in accordance with annex IX if the directive 93/42/EEC, which divide medical devices into Classes I, I with measuring function, I sterile, IIa, IIb and the highest risk class III. The MEDDEV guideline 2. 4/1 Rev. 9 describes 18 classification rules and their application over medical devices defined under the directive 93/42/EEC.
Conformity assessment route
Module A – Internal control of production
Manufacturer follows Annex VII and draw up EC declaration of conformity
Intervention by notified body is not required
Technical file must be prepared and kept according to the section 3 of Annex VII
Classification rules
Applicable classification rules for medical devices under the class I:
– Rule 1 – Devices that either do not touch the patient or contact intact skin only
– Rule 2 – Channelling or storing for eventual administration
– Rule 4 – Non-invasive devices which come into contact with injured skin
– Rule 5 – Devices invasive with respect to body orifices
– Rule 6 – Surgically invasive devices intended for transient use (< 60 minutes)
– Rule 12 – All other active devices
Conformity assessment route
Module H – Full quality assurance
Manufacturer follow Annex II (excluding section 4)
or
Module D – Production quality assurance
+
Module A – EC declaration of conformity
Manufacturer follow Annex V and Annex VII
or
Module E – Product quality assurance
+
Module A – EC declaration of conformity
Manufacturer follow Annex VI and Annex VII
or
Module F – Product verification
+
Module A – EC declaration of conformity
Manufacturer follow Annex IV and Annex VII
Classification rules
Applicable classification rules for medical devices under the class I sterile/with measuring function:
– Rule 1 – Devices that either do not touch the patient or contact intact skin only
– Rule 2 – Channelling or storing for eventual administration
– Rule 4 – Non-invasive devices which come into contact with injured skin
– Rule 5 – Devices invasive with respect to body orifices
– Rule 6 – Surgically invasive devices intended for transient use (< 60 minutes)
– Rule 12 – All other active devices
Conformity assessment route
Module H – Full quality assurance
Manufacturer follow Annex II (excluding section 4)
or
Module D – Production quality assurance
+
Module A – EC declaration of conformity
Manufacturer follow Annex V and Annex VII
or
Module E – Product quality assurance
+
Module A – EC declaration of conformity
Manufacturer follow Annex VI and Annex VII
or
Module F – Product verification
+
Module A – EC declaration of conformity
Manufacturer follow Annex IV and Annex VII
Classification rules
Applicable classification rules for medical devices under the class IIa:
– Rule 2 – Channelling or storing for eventual administration
– Rule 3 – Non-invasive devices that modify biological or chemical composition of blood, body liquids or other liquids intended for infusion into the body
– Rule 4 – Non-invasive devices which come into contact with injured skin
– Rule 5 – Devices invasive with respect to body orifices
– Rule 6 – Surgically invasive devices intended for transient use (< 60 minutes)
– Rule 7 – Surgically invasive devices intended for short-term use (>60 minutes, <30 days)
– Rule 8 – Implantable devices and long-term surgically invasive devices (> 30 days)
– Rule 9 – Active therapeutic devices intended to administer or exchange energy
– Rule 10 – Active devices for diagnosis
– Rule 11 – Active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body
– Rule 15 – Specific disinfecting, cleaning and rinsing devices
– Rule 16 – Devices to record X-ray diagnostic images
Conformity assessment route
Module H – Full quality assurance
Manufacturer follow Annex II (excluding section 4)
or
Module D – Production quality assurance
+
Module B – EC type examination
Manufacturer follow Annex V and Annex III
or
Module E – Product quality assurance
+
Module B – EC type examination
Manufacturer follow Annex VI and Annex III
or
Module F – Product verification
+
Module B – EC type examination
Manufacturer follow Annex IV and Annex III
Classification rules
Applicable classification rules for medical devices under the class IIb:
– Rule 3 – Non-invasive devices that modify biological or chemical composition of blood, body liquids or other liquids intended for infusion into the bod
– Rule 4 – Non-invasive devices which come into contact with injured skin
– Rule 6 – Surgically invasive devices intended for transient use (< 60 minutes)
– Rule 7 – Surgically invasive devices intended for short-term use (>60 minutes, <30 days)
– Rule 8 – Implantable devices and long-term surgically invasive devices (> 30 days)
– Rule 9 – Active therapeutic devices intended to administer or exchange energy
– Rule 10 – Active devices for diagnosis
– Rule 11 – Active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body
– Rule 14 – Devices used for contraception or prevention of sexually transmitted diseases
– Rule 15 – Specific disinfecting, cleaning and rinsing devices
– Rule 18 – Blood bags
Conformity assessment route
Module H – Full quality assurance
Manufacturer follow Annex II (excluding section 4)
or
Module D – Production quality assurance
+
Module B – EC type examination
Manufacturer follow Annex V and Annex III
or
Module E – Product quality assurance
+
Module B – EC type examination
Manufacturer follow Annex VI and Annex III
or
Module F – Product verification
+
Module B – EC type examination
Manufacturer follow Annex IV and Annex III
Classification rules
Applicable classification rules for medical devices under the class III:
– Rule 6 – Surgically invasive devices intended for transient use (< 60 minutes)
– Rule 7 – Surgically invasive devices intended for short-term use (>60 minutes, <30 days)
– Rule 8 – Implantable devices and long-term surgically invasive devices (> 30 days)
– Rule 13 – Devices incorporating, as an integral part, a medici nal product or a human blood derivative
– Rule 14 – Devices used for contraception or prevention of sexually transmitted diseases
– Rule 17 – Devices utilising animal tissues or derivatives
Process of medical device CE marking
CE marking process of medical devices is evaluation of conformity with essential requirements laid down by the directive 93/42/EEC. 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 medical device, in order to demonstrate compliance with applicable requirements. Common format used and widely accepted is document GHTF/SGlINOll:2008 STED (Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices) issued by Study Group 1 of the Global Harmonization Task Force.
The most Essentials part of technical files are clinical 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.
Clinical evaluation represents the most critical part of the technical file as the main assessment aspect is to prove clinical safety of the medical device under CE marking assessment. The MEDDEV guideline MEDDEV. 2.7.1 Rev.4 has been issued in 2016 as a new comprehensive revision since 2009. Even though the 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 shall 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 93/42/EEC requirements
Certification decision
- certification or notified body decides, based on the all particular assessment results whether manufacturer and its medical device meet all requirements and is possible to grant certification according to the directive 93/42/EEC
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
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