REGULATORY ASSISTANCE

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MEDICAL SURGICAL DEVICES (PMC)

MEDICAL SURGICAL DEVICES (PMC), include products that claim on the label an activity related to the following definitions, as defined in article 1 of the D.P.R. 392 of 6 October 1998:

  • disinfectants and germicides or bactericides
  • insecticides for domestic and civil use
  • Insect repellents
  • rat poisons for domestic and civil use
The Medical Surgical Device Technical-Regulatory Area of Bio Basic Europe assists the client by offering consulting services and producing the necessary documentation for the trading of the products, in line with the current regulations concerning safety and protection of public health.

Below is a list of the main technical-regulatory services offered by Bio Basic Europe for producers and manufacturers of medical surgical devices and other REACH products:

  • Advice on the current regulations (REACH) and national regulations (PMC)
  • Identification of the legal obligations within the supply chain of a product, according to the criteria set by the reference regulation
  • Contacts with national and international Authorities to meet regulatory requests
  • Evaluation of the category to which a product belongs, in case of a "borderline" classification
  • Analysis of the documentation necessary for the medical-surgical devices (PMC) registration
  • Advice on the analysis required by the relevant regulation
  • Documentation audit concerning electronic devices and CB reports, and labelling advice
  • Aerosol labelling advice and opinions on the metrological obligations, according to the vertical and horizontal regulations
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