The Best Plan for Diseases Diagnostics and Treatments
The regulation on medical devices allows the free movement of these goods in Europe and aims in particular to ensure that:
The regulations are based on several documents, including ordinances, international agreements, European directives, documents on the interpretation of these directives, harmonized technical standards and international consensus documents. Each time reference is made to these documents opposite. These rules are applied on all product suppliers such as Surgical products supplier, Cosmetics products supplier etc.
1.1. Legal bases and international treaties
The regulation on medical devices relies mainly on:
These agreements simplify advertising requirements for companies that place medical devices on the market and allow them to market their products directly from company to all EU and EFTA countries in Turkey without an agent having its seat in these different countries. For their part, companies with headquarters in one of the signatory states may market directly in medical devices that comply. However, the specific national requirements for medical devices remain applicable in the various Contracting States.
1.2. Delimitation between medical devices and other products
Each company should carefully consider the features and claims for its products to determine which laws apply. Medical use and therapeutic claims are only allowed for drugs and medical devices. In practice, the distinction between medical devices and the following product groups is particularly important:
Some medical devices may be subject to several regulations. These devices must then meet other requirements in addition to those of the LPTh and the ODim. They may be subject to additional notification or authorization procedures. Examples:
Personal protective equipment and machinery: where a medical device serves as a machine or is used in parallel as personal protective equipment, the essential requirements of the Machinery Directive and / or the PPE Directive must be met. also be complied with in addition to those that apply to medical devices.