Obtain CE Marking

European Union Technical File (Design Dossier) for CE Marking Approval

See all Benefits of INDEPENDENT regulatory representation and medical device registration services.

We help medical device and IVDs companies prepare the necessary documentation to achieve CE Marking certification for their products. A required component is the CE Technical File (called a Design Dossier for Class III devices).

A CE Technical File is a comprehensive collection of information and documents detailing everything about your medical device. Understanding how to assemble this information and present it properly is essential. If you manufacture a Class I device or self-certified IVD, a less complex CE Marking Technical File may be required. In the case of Class IIa, IIb and Class III devices (and Annex II, List A; Annex II, List B; or self-testing IVD), a more complex CE Technical File or Design Dossier must be prepared.

The EU Technical File is subject to review by a Notified Body if the medical device is Class I with measuring or sterile function, Class IIa, IIb, and III (Design Dossier), or if Annex II, List A; Annex II, List B; or self-testing IVD. Once placed on the market, national Competent Authorities have the right to review EU Technical Files regardless of classification at any time. An incomplete or improperly completed Technical File may result in unexpected delays or even prevent market entry. To learn how the Technical File fits into the CE Marking process, read the documentation explaining the European regulatory process.

The components of a CE Mark Technical File include: 

• Description of the product family and justification for why each product falls within the product family. 
• Detailed account of the intended use of the device(s) including how the medical device(s) functions, what it does, where the device is used, what it is used with, and who uses it. 
• Description of components, specifications, packaging and literature. 
• The manufacturing process. 
• Listing of accessories. 
• Location of design responsibility and manufacturing facilities. 
• Classification of the device and rationale for classification. 
• The chosen route to compliance according to the applicable Directives. 
• Declaration of Conformity that states the manufacturer's compliance with applicable Directive(s). 
• Lifetime/shelf life of products and environmental limitations. 
• Retention of QA, Competent Authority and Notified Body records. 
• Vigilance reporting and Medical Device Reporting procedure. 
• How and when to contact Competent Authorities. 
• Name of, and contract with, your Authorized Representative in Europe. Subcontractor names and addresses, if applicable. 
• Essential Requirements. 
• Design input specifications. 
• Application and references to Standards and Guidelines. 
• Testing results and clinical evaluations. 
• Risk analysis. 
• Instructions for Use and Labeling.

We compiled and reviewed CE Technical Files and Design Dossiers for hundreds of medical device and IVD companies. You can also read our in-depth article about the format and components of a Technical File

CE Technical File or Design Dossier compilation services comprises: 

Compile the EU Technical File or Design Dossier. Help you determine exactly which materials need to be assembled. Completely review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s). Determine applicable standards. Facilitate Risk Assessment. Review labeling and Instructions for Use. Develop and implement risk management process. Assist in writing the clinical evaluation summary. Our European Technical File preparation services are handled on a fixed price basis. 

CE Certification – CE Mark Certification for Medical Devices

In order to commercialize medical and in vitro diagnostic devices in the European Union, manufacturers must obtain CE Marking certification and affix the CE marking as part of their device registration efforts.

CE Marking certification verifies to EU regulators that your device meets all requirements of the Medical Devices Directive (MDD), In Vitro Diagnostic Device Directive (IVDD) or Active Implantable Medical Device Directive (AIMD) as they apply to your product. You must obtain CE Marking certification prior to marketing, distribution and sale of your product in any EU member state.

You are solely responsible as the medical device manufacturer for maintaining compliance with EU directives and securing CE Marking certification for your product, regardless of whether you outsource any or all components of your manufacturing operation.

Qualifying for CE certification and marketing your medical device in the EU requires the following steps:

1. Prepare a CE Marking Technical File or a Design Dossier for a Class III device that includes data proving compliance with the MDD, IVDD or AIMD.
2. Obtain your CE Marking certificate from an Accredited Notified Body.
3. Select and appoint a European Authorized Representative to act on your behalf within the EU.
4. Register your medical device with the appropriate Competent Authority, if necessary.

Completion of these requirements allows you to claim CE Marking certification for your device.

We have assisted hundreds of medical device manufactures with their CE Marking certification efforts. Services we provide to help you obtain CE certification include product classification; technical file and design dossier preparation; ISO 13485 quality system implementation and auditing; and ISO 14971 risk assessment and management needed for entering the European Union Market.

Please contact us for more information on the CE Mark certification process.

STED - Summary Technical Document Preparation 

A Summary TEchnical Document (STED) is a harmonized format for submitting information for regulatory approval of new devices. The STED format was created by the Global Harmonization Task Force (GHTF). The long term goal of STED is to globally standardize regulatory submissions. 
The five GHTF members are actively using or evaluating STED as a pilot program: Australia, the European Union, Japan, Canada and the United States. Canada now requires the STED format for Class III and IV medical device license submissions. In Japan, the Japanese submissions are essentially required to be in STED with more detail. The information required for the preparation of a Summary Technical Document (STED) is most similar to the documentation required for a European Technical File. Other countries around the world have begun to accept the STED or ASEAN CSDT. We have expertise in preparing submissions in the STED format and we can fully assist in preparing or reviewing submissions for your medical devices for any of the markets mentioned above.

Please contact us for more information on preparing or reviewing a Summary Technical Document (STED) submission.

In-Country Representation for Medical Device Companies

CLINICAL CONSULTING

Clinical Trial Study Design and Protocol Development

The clinical trial protocol describes the objective, rationale, design, methodology and organization of a clinical study. Careful planning and consideration of clinical trial study design is an important step in achieving the desired primary and secondary endpoints you desire in the most cost effective and timely manner possible. 

Depending on your ultimate goal, our clinical consulting team will work closely with you to ensure that the clinical investigation plan appropriately represents you to Institutional Review Boards (IRB)/Independent Ethics Committees (IEC) and adheres to Good Clinical Practice (GCP) guidelines, as well as all federal and local regulations.

Our clinical consulting team will help develop a clinical trial protocol which includes:

1. Introduction which includes general information on the sponsor and investigational device, as well as background information about why the trial is being conducted, a description of the trial purpose and objectives including a statement of primary and secondary endpoints
2. The Clinical Investigational Plan which includes the following information:
   • Study design, subject selection, inclusion, exclusion and withdrawal criteria
   • Efficacy and safety assessments and variables
   • Overview of trial procedures and methods of assessment
   • Treatment administration, packaging and labeling, storage, subject assignment, disposition and compliance requirements
   • Adverse Event (AE) reporting including definitions of adverse events, serious adverse events, device-related events, pregnancy, events of interest and collection and reporting requirements
   • Statistical methods to be used, sample size, analysis plan, termination criteria, randomization methods, etc.
   • Ethical considerations including a description of the role of the Independent Ethics Committee (IEC) or Institutional Review Board (IRB), ethical conduct of the study, subject information and consent
   • Data quality assurance, source documentation and case report form completion, monitoring expectations, data handling, record keeping investigator training, audit/inspection procedures and handling of Personal Health Information (PHI)
   • Investigator selection criteria, study completion procedures and reference list
   • If applicable, Healthcare Utilization Information (HUI) collection and analysis procedures, customized appendices such as the Investigator Agreement, List of Abbreviations and Definitions of Terms, Informed Consent Form (ICF) template, etc.

Depending on your budget and availability of in-house resources, Emergo Group can be involved in all or part of your clinical trial study design and protocol development.

Medical Device Clinical Trial Management and Monitoring

We works with medical device manufacturers to develop medical device clinical trial protocols and manage clinical trials to ensure successful outcomes. Our worldwide medical device clinical consulting headquarters is based in Europe with available consulting teams on all major medical device markets, from US to Japan. We have worked with each individual medical device company worldwide on regulatory compliance and clinical trial management projects.

Clinical trial monitoring for medical device studies

It is the responsibility of the clinical trial sponsor to ensure the safety of patients and maintain the accuracy and consistency of data collection during the trial. Our clinical trial monitors are medical device specialists and have been fully trained in Good Clinical Practice (GCP). Our medical device clinical trial monitoring services include:

• Overseeing progress of the clinical trial to ensure the study protocol is being followed and complies with GCP and ISO 14155.
• Monitoring enrollment of qualified subjects.
• Ensuring consistency of data collection and patient treatment across multiple sites and communicating/addressing deviations from the clinical trial protocol, SOPs, GCP, etc.
• Reviewing documents to verify that reports, submissions and other documents are accurate and up to date.
• Ensuring that adverse events are reported in accordance with GCP, the protocol, Independent Ethics Committees and any regulatory mandates.
• Preparing clinical monitoring outcome reports after site visits according to established SOPs.
• Compiling final clinical study report and study master files.

Our clinical trial management teams have vast experience with a wide range of medical devices, including many high-risk cardiovascular, orthopedic and combination products. If your company has existing clinical resources, we can work with you to provide some or all of the clinical trial management services listed above. Our ultimate goal is to reduce the time your trial takes and produce a positive outcome for the lowest possible cost.

Clinical Trial Management for Medical Devices in Europe

Are you preparing to undertake a clinical trial in Europe? Do you need help with surgeon or site recruitment? Do you know what ethics committee and competent authority approvals you will require?

We offer your company all our expertise in setting up, conducting and reporting clinical trials designed for:

• Demonstrating the clinical safety and effectiveness of a medical device for CE Marking.
• Obtaining post-market surveillance clinical data on devices with CE Marking.
• Obtaining health economic data to support obtaining reimbursement approvals.

Together we will design your clinical trial with appropriate study endpoints in mind. Whether you need to collect data to support CE Marking, a scientific publication, or drive marketing awareness/acceptance, we will develop your clinical study and help you to determine the optimal number of patients and study sites, study duration and length of follow-up.

Our clinical division offers comprehensive clinical trial management services covering everything from study design and protocol preparation to management of the study, data analysis and final reporting. Members of our clinical consulting team speak English, Italian, Spanish, German and French.

Our EU clinical trial management division offers a comprehensive range of services including:

• Physician/Surgeon/Medical center recruitment.
• Study design input & review - optimization of endpoints and scoring systems.
• Identification of qualified independent third parties to conduct radiographic data analysis.
• Preparation / review of study documentation (i.e. protocol, clinical investigation brochure, case report forms, patient information letters, informed consent forms, etc.).
• Competent Authority and Ethics Committee submission and liaison.
• Database design and validation.
• Arrangement of patient insurance.
• Study monitoring (initiation visits, routine intra-study visits and close-out visits).
• Preparation of monitoring outcome reports.
• Data collation and database input.
• Data queries handling, analysis and manipulation.
• Traceability to hard copy patient records and identification of duplicate entries.
• Final report and study masterfile compilation
• Project management of the clinical study.

Our medical device clinical trial management expertise covers a range of devices, with a focus on high risk products including cardiovascular and orthopedic implants. We have conducted prospective CE Marking and post-marketing surveillance clinical studies on drug / device combinations, including drug-coated cardiovascular implants and antibiotic impregnated dressings, both of which have provided valuable insight into the ethics committee and competent authority requirements for clinical studies involving drug / device combinations.

Clinical Evaluation Reports for Medical Devices Sold in Europe

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. Recital 8, which is in the preamble of Directive 2007/47/EC, makes the statement "clinical data, even for Class I devices, will generally be 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." All the documentation must be in compliance by March 2010 to be able to promote their prduct on European Union Market.

What is clinical data?

Clinical Data is an important component of the CE Marking process. It is defined and included 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 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."

How can we assist with the medical device Clinical Evaluation Report?

Clinical evaluation entails the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device. We are specialized in reviewing medical device clinical data, and we can ensure that your Clinical Evaluation Report meets all European requirements. We can assist you in developing a procedure to perform these Clinical Evaluation Reports or we can prepare them for you based on your procedures. If necessary, we can develop a protocol to methodologically search and evaluate journal articles and provide a synopsis.

Please read more to learn how we can help you obtain CE Mark Registration.

Benefits of INDEPENDENT regulatory representation

In the rush to introduce a new product, many companies give little thought to the appointment of their in-country regulatory representative and appoint a distributor to fulfill this important role. This can be a costly mistake.

We serve medical device and IVD companies worldwide, helping them register their qualitty product on European Market. You can reduce the cost while ensuring the quality standards of you r products using our services. We can act as your independent regulatory representative in European Union. Nearly all of our representation services are offered by us and NOT service partners, ensuring a consistent level of service and a single point of contact for you, ensuring clear and fast comunications.

Considering appointing a distributor as your in-country representative? Read this first!

In markets such as Japan, Australia, Mexico, Brazil and China, the in-country regulatory representative controls the device approval and/or device registration. If you appoint a distributor to this role instead of an independent regulatory representative, switching distributors becomes extremely difficult and may require starting the device approval process all over again if your distributor is not willing to cooperate. This can be extremely expensive as you would not be able to sell in the market until re-registration is completed. You would also be required to pay a new registration fee. In many markets your technical documentation, labeling, manuals and other information must include your in-country representative's name and address. If you elect to use a distributor and then decide to switch distributors, you will need to reprint labels, manuals, and deal with the issue of products already in the marketplace with that distributor's name on them. Plus, distributors do not like to see other distributors names on your labeling. Most distributors are not aware of the role of an in-country representative and the mandatory responsibilities that come with it and often elect to take on this responsibility to maintain control over your device on the market from a commercial point of view. A conflict of interest may occur in the event of recall and/or incident reporting between you (the manufacturer) and the distributor. If the regulatory authorities question an incident or a non-compliance that occurred in the distribution system, will your distributor defend their company or yours? The distributor is focused on sales and marketing, not on regulatory affairs. They may not keep you up-to-date on regulatory changes in the market and provide timely warnings when changes affect your devices.

We are an independent in-country regulatory representative for medical device companies worldwide. 

We can act as your representative in all European Union markets, promoting your brand and products, mediating your relations with Competent Authorities and retailers, as your Authorized Representative (EC REP) 

Contact us for more information on independent in-country representation services for any of the European markets.

Laptop Ultrasound Portable Scanner

Are you looking for a portable ultrasound laptop?

The newest portable ultrasound is the size of a cell phone and cost around 16.000euro.

It is indeed portable, is less than 180g with battery, without ultrasound probe attached. But unfortunately, the portable ultrasound scanner made ​​by General Electric, although it is indeed a color doppler having all important functions of a power doppler ultrasound machine, it doesn`t offer the reliability of a common color doppler ultrasound scanner. And because it has a very small screen (although I do wear glasses) I can not say that equals even the reliability a regular black and white ultrasound scanner. It is of course ideal in emergency situations, or in places where size matters, such as in the cosmic space or on sea ships or offshore platforms.

If reliability and portability is what you want from a portable ultrasound laptop, I think you would like very much an ultrasound laptop or tablet that is less than 1200g battery with everything in place and can be worn with ease in its special protective bag that comes supplied.

The advantages are clear: autonomy with 3-cell battery (expandable to 6) which takes about 2-3h ordinary examination (device enters sleep mode after 10 minutes without being used). Add the 3 USB 2.0 ports and memory card reader that you can use to save the images in BMP format or DICOM formats. Laptop portable ultrasound machine has its own operating system and can print directly to the printer via USB port.

There are a number of accessories and probes available, cardiovascular ultrasound probe, linear ultrasound probe, convex endovaginal ultrasound probes and endorectal ultrasound probes and even veterinary ultrasound probes; having standard interface makes them all compatible with these types of devices,  probes that are compatible between ultrasound laptop and with tablet ultrasound machine from different manufacturers.

The devices come with a protective heavy duty cordura bag, battery Li-Ion 2500mAh, 16V power supply and convex ultrasound probe that can be replaced upon request with any other model. You can also buy ultrasound probes separately. Request ultrasound probe byindividual model, providing the model or part number of your machine

In Romania, import and use of these devices is regulated by European standards 93/42/EEC, the importer will provide a certificate of conformity for each model. This certificate will need to register the device in accordance with national medical system.

All new appliances benefit from 18 months international warranty for defects in manufacturing or materials, engaging manufacturer to repair or replace defective parts in order to restore the optimum functionality of portable laptop ultrasound, or replacing it with a similar one if necessary. In this case, the data stored in memory can not be recovered, so we do recommend that you save everyting at the end of the working session on memory card or USB memory stick.

In post-warranty period, the manufacturer maintains guarantee for manufacturing defects and material, except parts that are subject to normal wear such as moving items if any, capacitors with liquid electrolytes and components of thermal nature.

If you can not be deprived of the device for a short period to perform warranty, we suggest you purchase one of the packages providing temporary replacement for your portable ultrasound laptop, available on this website. Also you can ensure the device for some accidents that may occur in some unpredictable situations, such as its use in disaster areas or areas with high-risk for electronic devices.