Medical Devices

Medical devices belong to a group of products whose main effect is based on physical mechanisms. In that, they differ from drugs whose main mode of action is based on pharmacological, immunological or metabolic principles.

Particularly for drug-like products containing natural ingredients, the Medical Device category opens up new innovative possibilities, as long as they can fulfill the appropriate requirements.

According to Directive 93/42/EEC, as amended by Directive 2007/47/EC, the following definitions apply for a medical device:

“Medical device means any instrument, apparatus, (…) or other article (…), intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease;
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
  • investigation, replacement or modification of the anatomy or of a physiological process;
  • control of conception,
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and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”

In contrast to the drug registration process, medical devices have to undergo a conformity assessment procedure, after which the product will receive a CE mark. All medical devices must fulfill the applicable “essential requirements” for safety, function, and labeling. This is compiled in a technical documentation, which has somewhat less strict requirements than those of a drug registration dossier. A medical device certification can be a time and money saving alternative to a drug registration. Once a product has received the CE mark, it can immediately be sold in ALL EU countries.

Certification as a medical device offers many attractive advantages that may be interesting for the manufacturer of natural health products. Take advantage of analyze & realize ag's many years of experience and expertise working in new market segments!

Product development

We develop new, innovative medical devices for you, as well as strategies for a successful certification and market introduction. Our services also include determining whether a product meets the regulatory requirements for a medical device, as well as the development of a project plan. Medical devices with natural ingredients very often fall into the borderline area, in which clear product categorization is not possible. Therefore, accurate assessment of the feasibility and chance of success is an important first step in the development of the product, in which we will support you.

A further area of our expertise is our competent scientific assistance. We employ the best test procedures (biological tests), perform the optimum clinical studies to determine the efficacy and safety, and optimize the production process for your products. We will also handle time and cost management for you.

 

Regulatory Affairs

Compliance of medical devices containing natural ingredients with the regulatory requirements is an important prerequisite for the long-term success of your product. a&r is a competent business partner with many years of experience in the medical device field.

Our services include:

  • Preparation of technical documentation for all classes of medical devices
  • Scientific advice concerning biological and clinical tests
  • Clinical evaluation
  • Initiating contact and correspondence with notified bodies inland and overseas
  • Assistance in finding the appropriate notified body
  • Consultation procedures for medical devices containing a drug substance (risk class III)
  • Risk management according to ISO 14971
  • Implementation of an appropriate quality management system in accordance with ISO 13485
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Our experience

In the past 10 years, analyze & realize ag has been involved in the certification of many medical devices in areas including wound healing, weight management, atopic dermatitis, herpes simplex, allergic rhinitis, and periodontosis. Many of these are borderline products, where clear product classification is usually not possible. In most cases we were able to ensure a successful market introduction. Our motivation is to develop the most promising strategy for our customers and then implement it successfully.