CE-Marking Complain Process

1. General Statement and aim of the EBCP CE Product complaint support activity.

2. Clarification as to the role, limits, and assistance of EBCP in individual cases.

3.  CE medical device regulations, policy and guidelines

4.  EBCP documentation and an information system for accidents, product failure, safety problems, and related reports.

5.  Websites and Links: useful EMC/safety information.

6.  EBCP Contact.

General Statement and aim of the EBCP CE-Product Complaint Support Activity

General Statement:

Since June 1998, CE Marking is a legal requirement stating that certain medical products sold to the countries of the European Union (EU) must be approved by a notified body indicating that they have met the essential requirements set out by the Medical Device Directives (MDD).

Although these requirements are six years ago, very little is known by the medical community regarding the steps in reporting product deficiencies and subsequent accidents.

The Aim of EBCP Support:

The EBCP is committed to providing assistance in this process by providing a central contact point through which questions may be directed regarding the steps involved in filing a product complaint and the contact numbers needed in reporting a product deficiency.

The EBCP intent is to improve patient safety through enhancing the initiation of a product complaint process and promoting the reporting of product deficiencies and any accidents related to a product by perfusionists.

Limits of the EBCP Role in Individual Product Complaint Processes

REPORTING OF CASES is a vital aspect of device regulation. Documenting strengths and weaknesses of devices after the product has been in clinical use for a number of years is the only way to maintain quality control, for it is only then that technical problems become apparent.

Responsible health care providers in the EU should report problems to the manufacturers and regulatory authorities so that hazards can be promptly identified. ________________

EBCP Assistance

The EBCP will help in this process by:

1) providing contact information and clarifying the possibilities and priorities involved in the reporting procedure for deficient cardiopulmonary related medical devices,

2) for action on the safety of cardiopulmonary related medical devices which may aid in presenting appropriate proposals, and

3) clarifying for health care professionals in the EU seeking advice in the reporting procedure and the issues related to perfusion products covered under CE Safety Compliance Requirements.

Clarification as to the Role, Limits, and Assistance of EBCP in Individual Cases

Clarification of EBCP Support:

The EBCP does not legally bind the itself to any complaint process, nor is it responsible for any misinformation which leads to a delay in problem reporting.

All information contained in a complaint process or incident report will be kept confidential unless it is deemed necessary by both the EBCP and those initiating the process.

Medical Device Regulations, Policy and Guidelines

The Medical Device Directives (MDD) consists of 75 pages (12 point) divided into: Introduction, Articles (23) and Annexes

"1; Definitions"

"Article   2; Placing on the market and putting into service"

"Article   3; Essential requirements"

"Article   4; Free movement, devices intended for special purposes"

"Article   5; Reference to standards"

"Article   6; Committee on Standards and Technical Regulations"

"Article   7; Committee on Medical Devices"

"Article   8; Safeguard clause"

"Article   9; Classification"

"Article 10; Information on incidents occurring following placing of devices on the   market"

"Article 11; Conformity assessment procedures"

"Article 12; Particular procedure for systems and procedure packs"

"Article 13; Decisions with regard to classification, derogation clause"

"Article 14; Registration of persons responsible for placing devices on the market"

"Article 15; Clinical investigation"

"Article 16; Notified bodies"

"Article 17; CE marking"

"Article 18; Wrongly affixed CE marking"

"Article 19; Decision in respect of refusal or restriction"

"Article 20; Confidentiality"

"Article 21; Repeal and amendment of Directives"

"Article 22; Implementation, transitional provisions"

"Article 23; This Directive is addressed to the Member States"

The Annexes describe in detail the :

"Annex I;" General requirements

"Annex II;" EC Declaration of conformity

"Annex III;" EC Type-Examination

"Annex IV;" EC Verification

"Annex V, VI, VII;" EC Declaration of conformity (Production quality assurance)

"Annex VIII;" Statement concerning devices for special purposes

"Annex IX;" Classification Criteria

"Annex X;" Clinical evaluation

"Annex XI;" Criteria to be met for the designation of a notified body

"Annex XII;"

CE Marking of conformity 

Documentation and an Information System for Accidents, Product Failure, Safety Problems, and Related Reports

Maintain documentation and an information system for accidents, product failure, safety problems, and related reports.

This information cannot be accessed online.

The EBCP will store and use the information as reference material and may provide comments and/or advice from its content which is found to be pertinent to a specific case or aid in reporting of medical device problems.

All information will be confidential so that the person (s) reporting a problem will remain anonymous.

Websites and Links: useful EMC/Safety Information.

The following websites are helpful in learning about CE Marking

The Gateway to European Union

www.europa.eu.int

Guidelines relating to medical devices Directives:

http://www.europa.eu.int/comm/enterprise/index_en.htm

Enterprise Europe Newsletter

The Enterprise Europe Newsletter is published quarterly in 11 languages and delivered by post free-of-charge anywhere in the world.

You can also consult or download electronic editions using the links on this page.

http://www.europa.eu.int/comm/enterprise/library/enterprise-europe/index.htm 

Guidelines relating to medical devices Directives

http://www.europa.eu.int/comm/enterprise/medical_devices/meddev/index.htm

Medical Devices Directive (MDD)

http://www.europa.eu.int/comm/enterprise/medical_devices/index.htm

List of Notified Bodies http://www.europa.eu.int/comm/enterprise/newapproach/legislation/nb/notified_bodies.htm

List of vigilance contact points within the National/Competent Authorities for...

AUSTRIA - BELGIUM - BULGARIA - CYPRUS - CZECH REPUBLIC - DENMARK - ESTONIA - FINLAND -

FRANCE - GERMANY - GREECE - HUNGARY - ICELAND - IRELAND - ITALY - LATVIA - LITHUANIA - LUXEMBOURG - MALTA - NETHERLANDS - NORWAY - POLAND - PORTUGAL - ROMANIA - SLOVENIA - SLOVAKIA - SPAIN - SWEDEN - SWITZERLAND - TURKEY - UNITED KINGDOM

http://www.europa.eu.int/comm/enterprise/medical_devices/ca/list_ca.htm 

List of Notified Bodies with CE Marking Number

http://www.europa.eu.int/eur-ex/pri/en/oj/dat/2003/c_302/c_30220031212en00010414.pdf

List of notified bodies designated by the Member States and the EFTA Countries (EEA Members) under the new approach Directives (Text with EEA relevance.) (The list also includes notified bodies from Candidate Countries as well as designated conformity assessment bodies from third countries with whom the EC has concluded a Mutual Recognition Agreement (MRA).)

Official Journal C 302 , 12/12/2003 P. 0001 - 0414

http://www.europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&numdoc=52003XC1212(04)&lg=EN

New Approach Standardization in the Internal Market

http://www.newapproach.org/home.asp

CEN, CENELEC, ETSI and their National Members

Nando Information System

This site will enable you to find the European notified bodies as well as third country bodies designated under formal agreements [Mutual Recognition Agreements (MRAs), Protocols to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products (PECAs) and European Economic Area (EEA)] responsible for carrying out the conformity assessment procedures referred to in the applicable New Approach directives.

http://europa.eu.int/comm/enterprise/nando-is/home/index.cfm

For further information: European Commission

Enterprise DG, unit G.1

B-1049 Brussels

Belgium

Fax: +32 2 295 97 84

E-mail: entr-regul-coord-mra@cec.eu.int

EBCP contact is..

Carole Hamilton

carole.hamilton@gmx.net 

The following document will help you to understand the CE-Marking and how to deal with.

CE-Marking Complain Process (Word)