Medical Products: Good to know

Definition of a Medical Product

Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, 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,

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.

Definition of Accessories

Accessory means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.

Essential Requirements - Annex 1

Medical product regulation states that medical products can be freely handled on the European market as long as they fulfill basic requirements: §7 of the MPG and directive 93/42/EWG, attachment I. The manufacturer confirms conformity of a medical product with basic requirements by labeling every single product with the CE mark. The basic requirements define the target of the presiding medical product directive in that they present a requirement profile for the medical product with which it should comply if it is to be handled freely on the European internal market. The basic requirements specifically cover:

  • Safety
  • Technical performance
  • Medical performance of the product

Technical safety requirements are proven fulfilled with the help of the conformity evaluation procedure, 93/42/EWG directive. It should be demonstrated that technical performance is up to scratch, while medical performance must be proven in terms of clinical evaluation. A product does not necessarily have to fulfill all basic requirements, rather only those appropriate for the product in question and directly related to the purpose of the product. Essentially, the manufacturer is nonetheless obliged to fulfill basic requirements, but the method in which they do this is left up to them.

TÜV Rheinland - "Notified Body"

Depending on the risk category of the product, you are required to commission a notified body to carry out an EG prototype audit, evaluation of a design dossier, or for auditing the quality management system. Together with you, we carry out the necessary conformity evaluation procedure for your products and company, meaning that you will receive your “driving license” for EU countries that bit quicker.

On top of that, we can offer an audit of your medical products for specific or voluntary market requirements.

Our Services

As a notified body, we carry out the following European homologation processes:

  • Conformity evaluation of active and inactive medical products
  • Conformity evaluation of active implantable medical devices
  • Conformity evaluation of in vitro diagnostics

Services as a Certified Institute for Quality Management Systems

  • EN ISO 9001 certification
  • EN ISO 13485 certification for medical product manufacturers
  • EN ISO 13485 certification for the preparation of medical products
  • EN ISO 15378 certification for primary packing material

Additional Audits

  • Ergonomics and user compatibility of medical products
  • Tested medical products
  • Lab products used in healthcare
  • Chemical audits, ROHS
  • Components

Conformity Proof Via The CE Mark

As a manufacturer of medical products, the CE mark helps document the conformity of your products with the following directives:

  • 93/42/EWG for Medical Products (MDD)
  • 90/385/EWG for active implantable medical devices (AIMDD)
  • 98/79/EG for in vitro diagnostics (IVDD)