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Key definitions according to European Directive

Notified body CE marking (CE 0197)

Certain devices where the criticality of the device is high such as ECGs, X-ray system etc., for this device, show compliance to the directives and standards is not sufficient however the same needs to be audited by authorized independent third party ‘so called’ notified body. In such cases the CE marking will be followed by four digit (CE 0197) number ‘so called’ notified body CE marking. The conformity assessment procedure gives guide lines regarding type of CE marking to be followed.

TUV Rheinland (Notified Body CE 0197) is a independent testing laboratory and/or certification body recognized in the EU to perform tests, review of the technical documentation & demonstrating compliance with the essential requirements, auditing the quality system with the standards of EN/ISO 13485; 2003 and issue reports and certificates of conformity. Test reports and certificates issued by Notified Body attest to a medical product or system's conformity to the relevant standards/ directives. These reports and certificates are the basis for mutual recognition of test results which build consumer confidence in a product's conformity.

Competent Authority

A Competent Authority is the body, which has the authority to act on behalf of the government of a member state to ensure that the requirements of the medical devices directives are carried out in that particular member state. For example in Germany ZLG is the competent authority, who will inform designated notified bodies and monitors the approval process.

Notified Body

TUV Rheinland (notified body) is a certification organization, which the national authority (the Competent Authority) of a member state designates to carry out one or more of the conformity assessment procedure according to MDD. For example TUV Rheinland is designated by member state Germany as a notified body, Each notified body will be assigned one unique four digit number which will be placed along with the notified CE marking. TUV Rheinland notified key number is 0197, hence notified CE marking issued by the TUV Rheinland will be CE 0197.

Manufacturer

The Regulations concerning medical devices define the manufacturer as the person who is responsible for the designing, manufacturing, packaging and labeling the device before it is placed on the market under his own name.

European Representative / Local Representative / Authorized Representative:

If your company does not have a physical location within the EU, European law for medical devices dictates that you must appoint a European Authorized Representative who is located within Europe to act as your liaison with the national Competent. Appointing MDSS as your European Representative will effectively put your company on the forefront of European Regulatory Requirements.

Roles of the European Authorized Representative:

  1. Registers your devices with the national Competent Authorities before they are marketed, where it is applicable.
  2. Acts as your primary contact point for all ‘National Competent Authorities’.
  3. Maintains a current copy of your ‘Technical File’ available for inspection by the European Competent Authorities.
  4. Gives you authorization to place our name and address on your device labels, packaging and Instructions for Use.
  5. Always available to interact between you and the National Competent Authorities.
  6. Responsible for Incident reporting to Competent Authorities, in cooperation with you and your distributors.
  7. Protects the confidentiality of your documentation. The European Authorized Representative can only show technical documentation to Competent Authorities as required by law.
  8. Represents you to the European Commission for consultation in case of withdrawal of a medical devices by a Member State(s).
  9. Maintains reports concerned to the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities.
  10. Notifies or is notified by, the Competent Authorities of serious device incidents.

European Union Member Countries

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

Own Brand labeling (OBL)

An “Own Brander” is the person who places the product on the market under his own name or trademark and therefore the manufacturer (as defined) for the purpose of the regulations.

List of Harmonized standard according to MDD

Annex-I Checklist of Medical Device Directive

All medical devices must meet the applicable “Essential Performance” on safety, performance and labeling as outlined in the Annex I of MDD (link). Safety requirement are not restricted to patient but includes operator and where applicable, other person.

Verification

Process of evaluating a medical devices or a component of a device to determine whether the products of a given development phase satisfy the specified requirements imposed at the start of that phase.

Validation

Process of evaluating a medical devices or a component of a device during or at the end of the development process, to determine whether it satisfies the requirements for its intended use.

Biocompatibility

Biological evaluation of the medical devices biomaterials interact with the human body according to ISO 10993 standards. The biological evaluation and test of medical devices is performed based on the nature of body contact and duration of contact.

Leakage Current

Electric current through a human body or through an animal body, when it touches one or more accessible parts of an installation or of equipment. Current which flows in a protective conductor is considered as earth leakage current.

Defibrillation Procedure

Defibrillation is the definitive treatment for the life-threatening cardiac arrhythmias, ventricular fibrillation and pulseless ventricular tachycardia. Defibrillation consists of delivering a therapeutic dose of electrical energy to the affected heart with a device called a ‘Defibrillator’.

This depolarizes a critical mass of the heart muscle, terminates the arrhythmia, and allows normal sinus rhythm to be reestablished by the body's natural pacemaker in the sinoatrial node of the heart. Defibrillators can be external, transvenous, or implanted, depending on the type of device used or needed. Some external units known as ‘Automated External Defibrillators’ (AEDs), automate the diagnosis of treatable rhythms, meaning that lay responders or bystanders are able to use them successfully with little, or in some cases no training at all.