1. OBLIGATIONS OF ECONOMIC AGENTS IN EUROPEAN REGULATIONS
A medical device (PS), active implantable medical device (PSIA) and in vitro diagnostic device (PDSIV) may only be placed on the European market or put into service if it complies with the provisions of Regulations (EU) 2017/745 and 2017 /746.
They will carry CE conformity marking that will be placed before the product is placed on the market. It will be followed by the identification number of the notified body responsible for the conformity assessment procedure.
The obligations of the economic agents (manufacturers, importers and distributors) who want to market these products are indicated below.
1.1. General obligations of manufacturers
They must have:
A) Technical documentation.
B) Clinical evaluation and post-marketing clinical follow-up.
C) Quality management system.
Evaluation of the Quality Assurance System, according to the harmonized standard UNE EN ISO 13485:2016. Medical devices. Quality Management Systems. Requirements for regulatory purposes
D) EU declaration of conformity and CE marking.
It consists of two parts:
Evaluation of the Essential Requirements, through the review of the technical documentation provided by the manufacturer.
Evaluation of the Quality Assurance System.
Quality management system and evaluation of technical documentation
Verification of product conformity
General safety and performance requirements
Design and manufacturing requirements
▫ Chemical, physical and biological properties
▫ Infection and microbial contamination
▫ Products that contain a substance considered to be a medicine and products that are composed of substances or a combination of substances that are absorbed by the human body or disperse locally in it
▫ Products that incorporate materials of biological origin
▫ Manufacture of products and interaction with their environment
▫ Products with diagnostic or measurement function
▫ Radiation protection
▫ Programmable electronic systems — products incorporating programmable electronic systems and computer programs that constitute products in themselves
▫ Active medical devices and products connected to them
▫ Particular requirements for active implantable products
▫ Protection against mechanical and thermal risks
▫ Protection against the risks that products that supply energy or substances may pose to the patient or user.
▫ Protection against the risks posed by medical devices intended by the manufacturer to be used by laymen.
Requirements regarding the information provided with the product. Label and instructions for use.
▫ General requirements regarding the information provided by the manufacturer
▫ Information that will appear on the label
▫ Information on the packaging that maintains the sterility of a product (“sterile packaging”)
▫ Information from the instructions for use
E) Risk management system.
Risk management process
The manufacturer can use the harmonized standard UNE EN ISO 14971. The risk management process must include the following elements in this order:
1.Identify the intended use and the qualitative and quantitative characteristics
2.Identify known hazards
3.Estimate the risk for each dangerous situation
4. Risk assessment/assessment using acceptability criteria
5. Risk reduction until acceptable
6. Implementation of control measures
7. Residual risk assessment
8. Benefit/risk analysis
9. Review of other hazards
10. Comprehensive risk assessment
Assessment of global residual risks
11. Assessment of global residual risks
12. Risk management report
Production and post-production information
13. Evaluation of production and post-production information
F) Unique identification system and registration obligations.
G) Financial coverage in relation to your possible liability.
H) Person responsible for compliance with regulations.
I) System to record serious incidents and corrective safety actions.
J) Post-marketing monitoring system.
K) Authorized Representative, when the manufacturer of the product is not established in a member state.
1.2. General obligations of importers
They will check that the following requirements are met:
CE marking and EU Declaration of Product Conformity.
The manufacturer is identified and has designated an authorized representative, if necessary.
Labeling and instructions for use necessary according to the Regulation.
Unique Identifier (UDI)
will indicate on the product or packaging or in a document accompanying the product, your name, your registered trade name or trademark, your registered office and address.
Registration in the electronic system. They will add your details to the registry.
While they are responsible for the product, they will ensure that the storage or transport conditions are those established by the manufacturer.
1.3. General obligations of distributors
They will check that the following requirements are met:
CE marking and EU declaration of conformity.
Adequate information on the label and instructions for use.
Unique Identifier (UDI)
While they are responsible for the product, they will ensure that the storage or transport conditions established by the manufacturer are met.
1.4. Cases in which the obligations of manufacturers apply to importers, distributors or other persons
A distributor, importer or other natural or legal person will assume the obligations of the manufacturer when they do any of the following activities:
a) Marketing a product under its own name, registered trade name or registered trademark, except in cases where a distributor or importer reaches an agreement with the manufacturer.
b) Change the intended purpose of a product already placed on the market or put into service.
c) Modify a product already placed on the market or put into service.
2. REQUIREMENTS FOR THE MANUFACTURE, IMPORT AND DISTRIBUTION OF MEDICAL PRODUCTS IN SPAIN
2.1. Requirements for manufacturing and import
The activities of manufacturing, importing, grouping, and sterilizing PS, PSDIV, PSIA, non-corrective contact lenses, and products for tattooing, micropigmentation, and permanent makeup using invasive techniques require a prior operating license granted by the AEMPS.
Activities that require an operating license:
- Serial manufacturers
- Custom manufacturers from the cities of Ceuta and Melilla
- Third party sterilizers
- Any of the following procedures:
- Sanitary products and their accessories
- Active implantable medical devices
- Medical devices for in vitro diagnosis and their accessories
- Non-corrective contact lenses not considered medical devices
- Apparatus and instruments used for permanent, semi-permanent makeup or skin tattooing by invasive techniques.
Companies/activities not subject to a license:
- Companies that, carrying out manufacturing phases or complete manufacturing for third parties of the products, do not market them in their own name, with the exception of sterilizing entities.
- Companies whose sole activity is the distribution of medical devices.
- Health product control laboratories. However, when a manufacturer contracts their services, said subcontracting will be reflected in the license issued to said manufacturer.
2.2. Specific requirements for community circulation and import
In addition to the prior license, each time they carry out an import operation from a third country of a PS included in the scope of their license (or their intermediates if the license is for manufacturing) they must pass a sanitary control, carried out in the customs control point at the entrance of the European Union. The EFTA countries (Norway, Liechtenstein, Iceland) are considered as countries of the European Union, as well as Switzerland, as long as the product to be imported originates and comes from Switzerland.
2.3. Distribution Requirements
The distribution of PS is not subject to a prior authorization requirement. However, whoever wants to engage in this activity must make a prior notification to the health authorities of the corresponding autonomous community.
3. OBLIGATIONS OF ECONOMIC AGENTS IN SPANISH REGULATION
The economic agents that intervene in the placing on the market and in service of Medical Devices are subject to the duty of communication of their activities in order to maintain the corresponding records, essential to be able to guarantee an adequate control of the products present in the market. In addition, the requirement of compliance with the traceability of the products placed on the market is important.
The Marketing Communication / Placing on the market and commissioning affects: Any natural or legal person who makes available for the first time, for distribution and/or use in Spanish territory, a product of class IIa, IIb, III, PSIA, self-diagnostic PSDIV or Annex II.
The Communication obligation for the Registry of those responsible for the placing on the market / marketing of products affects: Any manufacturer (or any RA established in Spain) of PS of class I, custom, PSDIV. Also to the groupers and sterilizers established in Spain.
The supplying company is obliged to provide Implantation Cards to the health center for the following implants:
- Cardiac implants and vascular implants of the central circulatory system
- Central nervous system implants
- Spine implants
- Hip prosthesis
- Knee prosthesis
- Breast prostheses
- Intraocular lenses
The implantation card will be in triplicate. One of the copies will remain archived in the patient's medical record, another will be provided to the patient and the third will be sent to the supplying company.