CE Marking: MDD info

MEDICAL DEVICES

Directive 93/42/EEC concerning medical devices

Short name:	Medical devices
Base:	Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ No L 169/1 of 1993-07-12)
Modification:	[-]
Directive repealed as from 1.1.1995:	76/764/EEC
Application Guide:	Guidelines relating to the demarcation between Directives 90/385/EEC, 93/42/EEC and 65/65/EEC Guidelines on a Medical Devices Vigilance System
EC contact point:	DG Enterprise & Industry Mr. M. Kohler Tel. +32 2 296 75 83, Fax. +32 2 296.70.13 e-mail: entr-cosm-med-dev@ec.europa.eu Website on Active Implantable Medical Devices

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Which classification does a Medical Device (MD) fall into?

A medical device (MD) may be classified as Class I (including Is & Im), Class IIa, IIb and III, with Class III covering the highest risk products. The higher the classification the greater the level of assessment required. All Class Is, Im, IIa, IIband III medical devices require the intervention of third party: the so-called Notified Body.

The classification rules are set out in Annex IX of the directive. This annex includes definitions of the terminology used in the classification rules. Classification of a medical device will depend up on a series of factors, including:

• how long the device is intended to be in continuous use
• whether or not the device is invasive or surgically invasive,
• whether the device is implantable or active
• whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device.

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!

Read more: Class I (including Is & Im) medical devices CE Marking procedures

For more information about classification rules, please visit Guidelines for Classification of Medical Devices.

Which category does an In Vitro Diagnostic Medical Device (IVD) fall into?

The IVD Directive (98/79/EC) groups IVDs into four categories. These categories are, in order of increasing perceived risk:

• Other Device:
  all devices except Annex II and self-testing devices);
• Device for Self-Testing (not listed in Annex II):
  a device intended by the manufacturer to be able to be used by lay persons in a home environment, excluding self-test devices covered in Annex II;
• Device of List B, Annex II
  of the Directive: which, amongst others, includes reagents and products for rubella, toxoplasmosis and phenylketonuria as well as devices for self testing for blood sugar;
• Device of List A, Annex II
  of the Directive: which includes reagents and products for human immunodeficiency virus I and II, hepatitis B, C and D.

Further info is available at
IVD-In Vitro Diagnostic medical devices CE Marking procedures
In Vitro Diagnostic Medical Device Directive, IVDMDD (98/79/EC).

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 from more than 100 of them based in 30+ countries; 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

1. Appoint Wellkang as your single European Authorized Representative within the 30 EU+EFTA countries.
2. Wellkang assist you in identifying all EU Directives applicable to your product.
3. Wellkang assist you in classifying your device.
4. Wellkang assist you in selecting the most appropriate conformity assessment module.
5. Wellkang assist you in selecting your Notified Body, if your chosen conformity module requires so, to perform the third-party conformity assessment tasks.
6. Wellkang assist you in assessing your device according to Essential Requirements.
7. Wellkang assist you in preparing the "Technical File".
8. Wellkang assist you in preparing your "Declaration of Conformity".
9. You affix the CE Marking on your device and start to sell.
   
   
10. 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:
    • 10.1 Publish Your Device:
      At webpage http://www.CEmark.info/mdd/YourProduct.html for third party verification
    • 10.2 Product Registration:
      If applicable, we can register your product in EU and get your product a Certificate of Registration.
    • 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.
    • 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.
    • 10.5 Legislation Monitoring:
      We monitor and report on new developments in European product legislation relevant to your products.
    • 10.6 Vigilance and Incident Reporting:
      We assist with product vigilance and incident reporting.
    • 10.7 Product Recalls and Advisory Notices:
      We assist with Product Recalls and the issuing of Advisory Notices

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:

• Dealing with the regulatory authority;
  
• 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;
  
• Register, Update, and/or Notify class I, and IVD, Medical Devices with the EEA Competent Authorities;
  
• Assisting in Vigilance/Incident Reporting, Product Recalls and the issuing of Advisory Notices.

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 30 EU+EFTA member states, therefore enjoy an effective and professional communication with the authorities and most favorable outcome for their businesses.

Why must inform/notify/register with the Competent Authority?

Both the Medical Devices Directive (93/42/EEC) and In Vitro Diagnostic Medical Device Directive (98/79/EC) require 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. These requirements have been transposed into national laws of the EEA Member States.

After the receipt of the notification/registration, the Competent Authorities shall process the data and inform the Commission of the European Communities and the other States Party to the Agreement on the European Economic Area, upon request.

When to inform/notify/register with the Competent Authority?

• For General Medical Devices:
  
  You must inform the Competent Authority when you first apply the CE marking to your class I device(s). If you have a number of models and the CE marking procedure is being introduced over a period, you may if you wish, inform the Competent Authority of all devices when informing of the first CE marking.
  
  Manufacturers of custom-made devices, systems or procedure packs, and sterilisation companies, should register no later than the first time they claim compliance with the Directive.
  
  
• For In Vitro Diagnostic Medical Devices (IVDs):
  
  For In Vitro Diagnostic Medical Devices there is a transitional period until 7 December 2003 in respect of a device placed on the market and a transitional period until 7 December 2005 in respect of a device put into service, during which a manufacturer can choose either to follow existing national regulations to apply the CE mark. You must inform the Competent Authority when you first apply the CE marking to your IVDs.
  

Who should apply/register with the Competent Authority?

The EEA Competent Authorities usually charge fees for the registration/notification.

• For General Medical Devices:
  
  You must register with the Competent Authority in an EEA Member State in which you have your registered place of business if you:
  • manufacture class I or custom made devices and place them on the market under your own name, or trading name(s);
  • 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;
  • 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;
  • 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;
  • are the authorised representative of a manufacturer who does not have a registered place of business in the EEA.
  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.


Custom Made Devices mean devices manufactured in accordance with a professional’s written prescription for the sole use of a particular patient and are not adapted from mass produced items.



• For In Vitro Diagnostic Medical Devices (IVDs):
  
  You must register with one Competent Authority in a Member State in which you have your registered place of business if you:
  • manufacture in vitro diagnostic medical devices (IVDs) and place them on the market under your own name, or trading name(s);
  • manufacture IVDs for performance evaluation and make them available under your own name, or trading name(s);
  • are the authorised representative of a manufacturer who does not have a registered place of business in the Community.
  If you do not have a registered place of business in a Member State and you wish to place IVDs on the European market then you must designate a person established in the Community to act on your behalf as your Authorised Representative.

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