Medical Device Regulation

Medical Device Technical Documentation

 

CE marking

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

CE 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.

Services we provide to help you obtain CE certification include product classification assistance, technical file and design dossier preparation, ISO 13485 quality system implementation and auditing as well as in-country representation and distributor search.

A CE Technical File is a comprehensive collection of data and documentation about your medical device. The information presented in the CE Technical File (Design Dossier for Class III devices) must demonstrate compliance with the Medical Devices Directive (MDD), In Vitro Diagnostic Medical Devices Directive (IVDD) or Active Implantable Medical Devices Directive (AIMD). We

  • Compile your 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 for your device.
  • Review your clinical data, compile a Clinical Evaluation Report (CER) and facilitate a Risk Assessment as necessary.
  • Review your proposed labeling and Instructions for Use.

 

Clinical Evaluation Report

Clinical evaluation report (CER) is a very important part of the CE marking process. Clinical evaluation is the assessment and analysis of clinical data related to a specific medical device to verify its clinical safety and performance. The evaluation is based on comprehensive analysis of pre- and post-market clinical data relevant to the intended use. This includes data specific to the device as well as any data relating to equivalent devices. The data can be from the literature and manufacturer sponsored clinical evaluation. The whole process is recorded in a CER which we will prepare for our clients.

 

Medical Device Representative

  • In-country Representation: Identification of which markets require local regulatory representation
  • Act as your official representative and a liaison between your company and Gosstandardt officials

 

Wireless compliance

Not only does the medical device with wireless function need to comply with national health regulations published to ensure patient and user safety, they must also comply with issues related to use of the wireless spectrum in a specific country.

Medical device manufacturers whose products rely on wireless and mobile technologies must deal with these additional complex regulatory requirements. More often, manufacturers of medical devices with wireless functionality (such as Bluetooth) must now address information security and electrical safety requirements in addition to standard regulations in some countries. We can assist clients achieve regulatory approval for their wireless medical devices, and can fully support your marketing authorization effort as well.

 

Post market surveillance

  • In recent years post-approval studies assessing real-life effectiveness, safety, patient outcomes and health economics of marketed products have evolved from optional “nice to have” marketing initiatives to mandatory requirements.
  • Governments, third party payers, patients and health care providers rely on the results of post-marketing studies for continued reimbursement support, demonstration of effectiveness and safety.
  • We identify post-market obligations you’ll have in terms of surveillance and vigilance in each of your countries of interest.
  • We design and execute post-marketing studies that adhere to rigorous principles of research that will generate evidence and answer valid scientific questions that warrant publications.