Let Imaqen build your bridges to Europe

Your company can save time and money by using the Imaqen IPR and Medical Device Consulting services.

Our services include:

Assistance with product classification
Verify applicable standards and testing requirements
Technical File or Design Dossier compilation, or review of your files
Review existing marketing materials, labelling, and user manual information to ensure compliance and consistency
Verification of compliance with Essential Requirements
Preparation of Clinical Evaluation Report based provided clinical data Implementation, modification, and maintenance of a quality system (usually ISO 13485) that will meet European and other international requirements
European Authorized Representative services
Risk assessment and management (ISO 14971)
Development of vigilance and post-market surveillance procedures

Medical Device CE-Assistance

Obtaining the CE-mark for your medical device takes you one step closer to entering the European healthcare market

Our experts take care of the process for obtaining the CE-mark so that you can concentrate on your core competencies.

Here is how the Imaqen CE-Assistance work:

We help you to classify of your Medical Device: Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive(98/79/EC) or Active Implantable Medical Devices Directive (90/385/EEC)
We help you to understand to importance of the term “intent of use”
Does your product require a Quality Management system? If yes, we can implement it for you
We prepare a CE Marking Technical File or a Design Dossier
If your company does not have a physical location in the EU, Imaqen Ltd. can serve as your European Authorized Representative (EC REP)
Have your QMS and Technical File/Design Dossier audited by a Notified Body, unless your device is Class I, is not sterile and has no measuring function.
We help you earn to CE mark for your product and to obtain the ISO 13485 quality -system (and obtain the EC Certificate from your Notified Body, if necessary)
Prepare a Declaration of Conformity (DoC), which states that your device complies with the appropriate Directive

Please contact us for more information on our services and why you should choose Imaqen as your CE assistance.

European Authorized Representative

Why do you need a European Authorized Representative?

If you are a manufacturer based outside of the European Union and intend to sell your medical devices onto the European Market, the legislation requires you to appoint an Authorized Representative within the European Union who may represent you in contacts with regulatory authorities and who may act on your behalf. Imaqen EAR Services can offer you such services.

Based on legal requirements of the European Directives 93/42/EEC (the MDD), 98/79/EC (the IVDD) and 90/385/EEC (the AIMDD) for non-European Manufacturers, you are required to appoint an Authorized Representative (EC REP) to represent your company to European authorities if your company does not have a physical location in the EU. Imaqen EAR acts as an intermediary between your company and the local competent authorities like Ministries of Health. You must maintain an EC REP as long as your devices are sold in Europe.

The service package is always tailor-made to meet the precise needs of the device manufacturer. Our service package could include;

Obtaining the CE mark – Technical File review on completeness
Use of Authorized Representative’s name and registered address in Europe on product label
An office address for mail, a phone and fax number
Notification to the Competent Authorities of the CE Declaration of Conformity (class I devices), and notification of changes to the Competent Authority
Administration of the Technical File; presentation of the contents of the file to Competent Authorities (upon request, only after Manufacturer’s written approval)
Technical representation, assistance in determination of the severity and impact, and reporting in case of incidents reported by users, distributors or national competent authorities
Up to date expertise on the latest MEDDEV instructions
Guidelines relating to Vigilance requirements and Authorised Representative requirements (i.e. contractual regulatory compliance)
Representation before the European Commission and national Competent Authorities in case of recall or risk for Product withdrawal from the market
Optional: Clinical representation, communication of relevant clinical data to the Competent Authority, Imaqen EAR Services can be delegated tasks relating to clinical investigations as the Imaqen Group also offers Clinical (investigation) services

Please contact us for more information on our services and why you should choose Imaqen as your EAR in Europe.

Clinical data and Clinical Evaluation Reports for Medical Devices

Clinical Data is an important component of the CE Marking process

European Directive 2007/47/EC, which amends the EU Medical Devices Directive MDD 93/42/EEC (and Active Implantable Medical Devices Directive AIMDD 90/385/EEC), places greater emphasis on clinical data and a Clinical Evaluation Report (CER). Recital 8, which is in the preamble of Directive 2007/47/EC, makes the statement “clinical data, even for Class I devices, is generally required.” Also, Annex I, Essential Requirements now states: “Demonstration of conformity with the Essential Requirements must include a clinical evaluation in accordance with Annex X.”

The definition of clinical data and a Clinical Evaluation Report (CER) is in Article 1.2 (k): “The safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:

Clinical data are obtained from one of these sources:

clinical investigation(s) of the device concerned; or
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.

Please contact us to find our more about this service and why you should choose Imaqen Clinical Evaluation Report (CER) assistance.

Have any questions? Give us a call or contact us by e-mail.

info@imaqen.com