The medical device landscape is enormous: According to a BVMED industry report, more than 200,000 people in Germany currently work in this industry and the trend is rising. The growth of this market is also reflected in regulation in the form of new laws, product standards or other national requirements. Whether the medical device is a hip prosthesis, CT scanner, defibrillator or scalpel, technical documentation must be created and maintained to provide documented proof of conformity with the medical device directive, regulation or any other national regulation.

Risk Classification of Medical Devices
Medical devices are divided into four risk classes: I, IIa, IIb and III. In addition, there is a distinction for Class I devices with sterility (attribute „s“), measurement function (attribute „m“) and reusable surgical instruments (attribute „r“). The classification is carried out with the help of classification rules, which derive a risk class from specific questions about the intended purpose of a medical device. Due to the new regulations, many medical devices are either completely reclassified or assigned to a higher risk class. Pure software products (stand-alone software such as mobile apps) are assigned to Class IIa or higher. This has far-reaching consequences, as different types of approval – the conformity assessment procedures – apply to different classes of medical devices.

Conformity Assessment Procedure
The conformity assessment procedures define the process for determining whether medical devices conform to the requirements of the regulation. In principle, it is the manufacturer’s responsibility to ensure this. For products in the risk classes Is, Im, Ir, IIa + IIb and Class III, a notified body is also involved. Within the scope of these conformity assessment procedures, this notified body checks the technical documentation of the device provided by the manufacturer and confirms conformity by issuing a certificate.

This documentation contains defined contents, which are specified by device-specific (harmonized) standards and in the future also by common specifications as well as applicable regulatory requirements (Regulation on Medical Devices (EU) 2017/745) and other applicable EU law (e.g. Machinery Directive).

The manufacturer may use the certificate to demonstrate conformity and as a basis to use the CE mark on its products.

CE Marking
In the European Economic Area (EEA), manufacturers require a CE marking to indicate the medical device conforms to the law. The CE marking serves as a visible indicator that the product meets the safety and performance requirements for medical devices and may therefore be marketed in the European Economic Area. Based on mutual recognition agreements, countries that are no member states of the European Union may also apply this approach.

Technical Documentation
Medical device manufacturers must provide technical documentation for each medical device. Depending on the device’s intended purpose and risk classification, specific requirements for the technical documentation must be implemented. These result from the applicable basic safety and performance requirements and the associated applicable standards and guidelines.

Technical documentation includes:

  • General information
  • Intended use and description of the product also via claims
  • Technical data of the medical device
  • Checklist of essential safety and performance requirements (Annex I)
  • List of applied standards with status of issue and indication of degree of application (complete/partial)
  • Risk management, usability and clinical evaluation
  • Evidence of compliance with post-market surveillance requirements (Annex III)
  • Proof of verification and validation for the implementation of product requirements
  • Instructions for use, accompanying documents and labelling including UDI

How We Can Help
We offer a comprehensive range of services for the approval of your medical products and preparation of technical documentation:

  • Identifying the product classification according to EU MDR and EU IVDR
  • Developing a suitable approval strategy (medical device, IVD, combination products, machines, etc.)
  • Identifying applicable (harmonized) standards and guidelines
  • Preparing the necessary technical documentation for approval of all medical device classes
  • Developing and implementing labelling for medical products (UDI, electronic instructions for use)
  • Developing procedures for identification and implementation of requirements from updated standards, guidance and directives or common specifications

We support you in identifying and implementing the requirements for the content of the technical documentation. We are also experienced in standardization, risk management, usability, software development/health software, clinical evaluation and testing. We can also provide comprehensive expertise on cybersecurity, data protection regulations and data integrity.

For further details on technical documentation or for a non-binding offer, please contact us or find out about our latest seminar.