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The Medical Devices Directive is concerned with all medical devices, from sterile Gants to electronic monitoring equipment and complex MRI-scanners.
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices
Class I equipment
Class 1: non-invasive electric/electronic equipment without a monitoring function.
For this type of medical equipment the so-called manufacturers declaration is applicable and no involvement of any certified or notified body is required. Most Class 1 equipment is not invasive at all, and should not administer anything to the patient, no medicines nor energy.
Class II equipment
Class II : non-invasive or short time invasive equipment or intensive patient skin contact or administration of body fluids or medicinal fluids or gases.
Class II equipment requires the involvement of a Notified Body that will approve customers documentation.
Technical Construction File
A Technical Construction File (TCF) is mandatory. The full construction details of the equipment and all measures taken to comply to the directive's Essential Requirements must be created and maintained.
Risk Assessment
Any medical device requires a risk assessment according to EN 14971:2007. This includes not only a analysis of construction, applied materials, energy flows, bio-compatibility , infection and cross infection risks and many other product properties, but also assesses the way the risks of the product are managed within the organization.
Essential requirements
The Medical Devices Directive uses harmonized standards to show presumption of compliance with the essential requirements of the directive. For Class I and II equipment these requirements are:
Harmonized standards
EMC
The equipment should comply with EN 60601-1-2:2001 and most often one of the many subparts.
Electrical Safety
The equipment should comply to EN 60601-1:2007.
Risk Management Assessment
A full risk assessment is part of the approval procedure for medical devices. ce-test may perform such a risk assessment according to the FMEA (Failure Mode and Effect Analysis) and a bi-directional TOP-DOWN-TOP FTA (Fault tree Analysis) methods. Other methods are acceptable.
Traceability
Products need to be fully traceable, both at the production stages (where do components come from) and in the marketing stage (to who the products are sold)
Quality control of production
Production of medical devices need to be under control of an intern manufacturing control system like ISO 9002 or better.
Vigilance
The manufacturer needs to set up and maintain a system where accidents and "near accidents" with the device will be adequately reported to the authorities. In combination with the required traceability of the product, this will allow product recalls if required.
Post market surveillance
The manufacturer needs to watch for any improvement to the safety of the product -to the state of the art-, and implement them in the final product as soon as possible, even after the product has been brought on the market.
Testing
The EN 60601 standard contains extensive requirements for patient touch current, dielectric testing and single fault requirements as well as EMI and susceptibility tests.
Labeling
Products need to labeled so as they can be used safety by the addressed customer. This includes a set of warnings and markings for common hazards, such as sterilization warnings, date of use, and other warnings. A number of symbols have been defined in EN 980:2008 that may be used without further explanation.
example
- Dry sterilizer (Class I)
- Tactile vibration test generator (Class I)
- Tactile hot-cold test generator (Class I)
- Nurse calling system for hospital including medical alarm
(Class IIb)
- Bed wetting alarm (Class IIa)
- Medical gas alarm (Class I)
- Infusion pump (Class IIa)
CE Legal basis for medical devices
Directives
Medical Devices are regulated in EEA- European Economic Area (EEA=EU+EFTA, totally 28 member states) by 3 New Approach Directives.
Authorities
Each EEA member state specifies some Competent Body(ies) (CB), also called "Competent Authority(ies)" to enact the directive within its territory. Each CB can specify one or more Notified Bodies (NB), to act as third party accessors of the manufacturer compliance. A NB may be Notified for accessing the products under all allowed conformity modules under the particular directive or only part of modules. Therefore, it is very important to select the most appropriate NB according to the manufacturer's own need.
Other Related Directives
Some other important directives may relate to the Medical Devices are:
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General Product Safety
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Machinery
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Low Voltage
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EMC
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Medical device CE Marking procedures
Depending on the individual case, each Medical Device manufacturer must choose its own and most suitable conformity module(s) which address(es) its particular product categories and business needs.
It is very important to select your European Authorized Representative like Wellkang before you choose a Notified Body among nearly 100 of them; As your Auth Rep, Wellkang will particularly assist you in classifying your product before submission to the most suitable Notified Body.
Steps to obtain CE Marking for your Medical Devices
- Appoint Wellkang as your single European Authorized Representative within the 28 EU+EFTA countries.
- Wellkang assist you in identifying all EU Directives applicable to your product.
- Wellkang assist you in classifying your device.
- Wellkang assist you in selecting the most appropriate conformity assessment module.
- Wellkang assist you in selecting your Notified Body, if your chosen conformity module requires so, to perform the third-party conformity assessment tasks.
- Wellkang assist you in assessing your device according to Essential Requirements.
- Wellkang assist you in preparing the "Technical File".
- Wellkang assist you in preparing your "Declaration of Conformity".
- You affix the CE Marking on your device and start to sell.
- Wellkang EU Authorized Representative Service AFTER you have affixed CE Marking on medical device
Wellkang continue acting as your Auth Rep for vigilance and inspection purpose while your CE-Marked devices are placed on the European market by you directly or through your local European distributors. Our service mainly covers the follows:
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10.1 Publish Your Device:
At webpage http://www.CEmark.info/mdd/YourProduct.html for third party verification
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10.2 Product Registration:
If applicable, we can register your product in EU and get your product a Certificate of Registration.
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10.3 Renewal and Update Product Registration:
The product Certificate of Registration is valid for one year only and must be renewed annually. The information about the product must be updated whenever it changes and at least once a year when renew the product Certificate of Registration.
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10.4 Keep Your Technical Files:
We store and update the Technical Files of your products sold in Europe. The Technical Files may be inspected at any time by the Competent Authorities for a period ending at least five (5) years after the last product has been manufactured.
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10.5 Legislation Monitoring:
We monitor and report on new developments in European product legislation relevant to your products.
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10.6 Vigilance and Incident Reporting:
We assist with product vigilance and incident reporting.
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10.7 Product Recalls and Advisory Notices:
We assist with Product Recalls and the issuing of Advisory Notices
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Why must a non-EU manufacture of medical device appoint a European Authorized Representative?
The European Union's 'New Approach Directives' are mandatory on all member countries to enact through national legislation. This legislation requires manufacturers to display  Marking on their products, packaging and accompanying literature. Where a new approach directive is in force, it is (with few exceptions) "an offense to place a product on the market without Marking". The manufacturer is legally responsible for ensuring that the product confirms to the requirements of the directive and for applying Marking.
For medical devices, it is compulsory, under the 3 Medical Devices Directives, that the non-EU manufacturer must appoint an Authorized Representative (authorised representative) which must be established (have a registered business) in the European Union member states to act on manufacturer's behalf in carrying out certain tasks including:
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Dealing with the regulatory authority;
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Keeping, for a period extending to at least five (5) years after manufacture of the product, the updated Technical Documentation (or Technical File) available, in a timely fashion when called upon, for review and inspection by EU Competent and/or Surveillance Authorities;
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Register, Update, and/or Notify class I, and IVD, Medical Devices with the EEA Competent Authorities;
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Assisting in Vigilance/Incident Reporting, Product Recalls and the issuing of Advisory Notices.
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To maintain the independence from distributors and importers, many non-EU manufacturers prefer to use Wellkang, a world-leading CE marking consultancy, as the European Authorized Representative acting as the central point to the government authorities in all 28 EU+EFTA member states, therefore enjoy an effective and professional communication with the authorities and most favorable outcome for their businesses.
Why must inform the Competent Authority?
The Medical Devices Directive 93/42/EEC requires manufacturers or, their authorised representatives or others placing medical device(s) on the EEA market, to provide certain information to the Competent Authorities in the EEA Member State where they have a registered place of business.
Who should apply/register with the Competent Authority?
You must register with the Competent Authority in an EEA Member State in which you have your registered place of business if you:
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manufacture class I or custom made devices and place them on the market under your own name, or trading name(s);
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fully refurbish class I devices, or label one or more ready made devices, with a view to placing them on the market under your own name;
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place devices bearing the CE marking on the market, under your own name in a system or a procedure pack within their intended purposes and within the limits of uses specified by their original manufacturers;
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sterilise, for the purpose of placing on the market under your own name, systems or procedure packs or other CE marked medical devices designed by the manufacturer to be sterilised before use;
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are the authorised representative of a manufacturer who does not have a registered place of business in the EEA.
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If you do not have a registered place of business in the EEA Member State you must designate an authorised representative established in the EEA to act on your behalf. The EEA Competent Authorities usually charge a fee for the registration.
Changes to registered details?
After the product registration or notification, the manufacturer or its authorised representative must inform the Competent Authority about any changes or additions to the registered details. Additionally, the Competent Authority will regularly review the records and request updating/confirmation of the registered information. The EEA Competent Authorities usually charge a fee for the product updating (change of registration).
Is my product a Medical Device?
For a number of products it is not clear if they are medical devices or not. There are a number of examples of products that may or may not be medical devices depending on the Intended Purpose for Use, assigned by the manufacturer to the products.
The following Toiletry and Cosmetics Products can also be Medical Devices if a medical claim is being made by the manufacturer for the device, although these products are usually not Medical Devices:
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tooth brushes, dental sticks, dental floss, dental chewing gums;
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baby nappies, hygiene tampons, mattress protectors;
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contact lenses intended to provide colour to the eyes;
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instruments for tattooing;
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deodorants for use with devices;
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wigs.
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(普通)医疗器械 Medical Devices
A "Medical Device" is defined in Directive (93/42/EEC) as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :
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diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap.
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investigation, replacement or modification of the anatomy or of a physiological process.
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control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means. more >>
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主动可植入医疗器械 Active Implantable Medical Devices
The "active medical device" means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity
The "active implantable medical device" means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure. more >>
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体外诊断医疗器械 In Vitro Diagnostic Medical Devices
The "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.. more >>
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非自动称量仪器 Non-automatic Weighing Instruments
A "Weighing Instrument" is defined as a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics.
A "non-automatic weighing instrument" is defined as a weighing instrument requiring the intervention of an operator during weighing. more >>
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Which classification does a Medical Device fall into?
It is usually the Intended Purpose for Use that determines the class of the medical device and not the particular technical characteristics of the device.
It is the Intended Purpose for Use, assigned by the manufacturer to the device, that determines the class of the medical device and not the class assigned to other similar products manufactured by the same manufacturer or different manufacturers. For instance, two sutures that have the same composition may well have different Intended Purpose.
A manufacturer may successfully avoid the particular higher classification by clearly define on the labelling the Intended Purpose in such a way that the device falls into the lower class!
For more information about classification rules, please visit Guidelines for Classification of Medical Devices.
Information is obtained from Wellkang
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