CE mark stands for Conformité Européenne. It is the gateway for the companies who want to export their products to Europe. The European community has implemented a system to protect the health of consumers and users of manufactured products. CE Mark assures the user of a product that the product conforms to the requirements of relevant directives of European union and harmonized European standards. The License is granted by agencies notified by European union.

CE mark stands for Conformité Européenne. (French for "European Conformity") but is not defined as such in the relevant legislation. The CE mark indicates that the product may be sold freely in any part of the European Economic Area, irrespective of its country of origin.

CE Marking certification helps you Market your products to the following countries

• Austria
• Belgium
• Cyprus
• Czech Republic
• Denmark
• Finland
• France
• Estonia
• Germany
• Greece
• Hungary
• Iceland
• Ireland
• Italy
• Luxembourg
• Latvia
• Lithuania
• Malta
• Netherlands
• Norway
• Portugal
• Poland
• Slovakia
• Slovenia
• Sweden
• Spain
• United kingdom

EU MDR 2017/745

The manufacturers, authorised representatives, importers or distributors of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices need to know how to comply.

The step by step guide to complying with the European Union's Medical Device Regulation of 2017.

• Decide the intended use and classification of your medical device
• Establish the necessary processes and resources
• Minimise the risks and fulfil the general safety and performance requirements
• Complete the clinical evaluation
• Compile the technical documentation
• Register the device and the manufacturer
• Complete the conformity assessment
• Fulfil the ongoing obligations in the post launch phase

MDD 93/42/EEC

The Medical Device Directive 93/42/EEC(MDD) :

The European medical device directive makes it mandatory as of 06/28/1998 to fulfill CE certification requirements in order to export medical devices, of Class I, IIa, IIb, and III to any country within the European community.

Medical Device classification in a nut shell (see 93/42/EEC) :

First step for compliance to MDD is to determine classification of your device by using Annex IX of the Medical Device Directive. The classification is similar to the FDA's, except for the sub-classification of (a) and (b) for class II products. Class I is for low risk device, while Class III is for the higher risk devices. The Here are examples of classifications

Class I :

• Wheel Chairs, Patient electrodes, Scalpels, Dental Drills, Wound Management systems, Hearing Aid Tester

Class IIa :

• All patient monitoring equipment, Syringes, Needles, Ultrasound devices, External ECGs, Diagnosis devices

Class IIb :

• Lasers Devices for application, Internal ECGs, RF Generators, Non-energized implants, Treatment devices

Class III :

• Energized implants, All Intracardiac applications, Heart valves, Cauterters, Non-energized implants, All devices in contact with the central nervous system

Recommended compliance routes :

Class I :

• Prepare Technical documentation*
• Fulfil requirements written in provisions of the procedures referred to in Annex IV, V or VI of 93/42/EEC for "sterile" or "Measuring" function devices. Ensure that medical device fulfills the essential requirements as laid out in Annex I of MDD using relevant harmonized standards.
• Conformity assessment does not require a notified body.Issue a Self-Declaration of Conformity according to Annex VII and affix CE mark on products.

Class IIa & IIb :

• Prepare Technical documentation*
• Ensure that medical device fulfills the essential requirements as laid out in Annex I of MDD.
• Implement Quality Management System in accordance with Annex II or V of the MDD. Most companies choose to obtain ISO 9001/ISO 13485 certification.
• Audit by notified body according to Annex II. Prepare a Declaration of Conformity, which states that the product is in compliance with applicable directive and affix CE mark.
• on products after successful audit.

Class III :

• Prepare Technical documentation*
• Implement Quality Management System in accordance with Annex II or V of the MDD. Most companies choose to obtain ISO 9001/ISO 13485 certification.
• Ensure that medical device fulfills the essential requirements as laid out in Annex I of MDD.
• Audit by notified body according to Annex II.
• Product Dossier Exam by notified body according to Annex II. Prepare a Declaration of Conformity, which states that the product is in compliance with applicable directive and affix CE mark.

If your company is not located in Europe, you must appoint an Authorized representative based in Europe. The Authorized representative will be responsible to handle regulatory compliance from within Europe and thus have access to technical documentation and product information. The contact information of the Authorized representative is mentioned on relevant documentation such as IFU, device labelling and Declaration of conformity.

*Technical File Content :

General product description, design drawings, methods of manufacturing and diagrams of components and sub-assemblies, description and explanation of above-mentioned drawings and diagrams, result of risk analysis and list of standards referred to in Article 5 of 93/42/EEC, applied in full or in part and descriptions of the solutions adopted if not applied in full. Description of the methods used if the device requires sterility. The results of the design calculations and of the inspections carried out. If the device is to be connected to other device(s), proof must be provided that it conforms to the essential requirements when connected. The test reports and where appropriate, clinical data in accordance with Annex X of 93/42/EEC and the label and instructions for use.