The regulation on medical devices allows the free movement of these goods in Europe and aims in particular to ensure that:
- the devices fulfill the essential requirements concerning their safety and performance;
- manufacturers, traders, professional users, conformity assessment bodies and authorities fulfill specific obligations to protect patients and third parties from danger and deception
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:
- the Federal Law on Medicines and Medical Devices
- the Medical Device Ordinance
- the Federal Law on Research on Humans
- the Clinical Trials Ordinance for Human Research
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:
- everyday items (e.g. personal hygiene items, cosmetics including teeth whiteners)
- personal protective equipment
- Electrical installation
- Products intended for general laboratory use.
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:
- non-invasive substances and preparations that do not come into direct physical contact with the body: European legislation on chemicals (classification, packaging and labeling);
- medical devices containing mercury or other dangerous chemicals: Ordinance on the reduction of risks related to chemicals;
- medical devices with ionizing radiation: law on radiation protection;
- disinfectant products: depending on the intended use the product is to be considered as a medicine, medical device or as a chemical (biocide);
- medical devices with radio frequencies: telecommunications law;
- pressure equipment and simple pressure vessels (eg medical gas dispensing systems, sterilizers, compressed air systems): Pressure Equipment Ordinance and Ordinance on Simple Pressure Vessels;
- devices containing narcotic drugs: the Narcotics Act;
- genetic tests: law on human genetic analysis and law on DNA profiles.
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.