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Marketing and registration
In order to ensure that a medical product complies with the rules and regulations established by the competent authorities before it is placed on the market and marketed, it is essential to carry out a registration in the databases of the authorities of the country in which it is manufactured. In the case of Spain, this task must be carried out under the perceptions of the Spanish Agency of Medicines and Health Products (AEMPS). This process is essential to ensure the safety, efficacy and quality of the products that will reach patients and healthcare professionals.
What is the registration of medical devices?
Registration of medical devices is a procedure by which manufacturers, importers or distributors must obtain approval from the competent health authorities to market their products. This registration involves a detailed evaluation of the product, including its design, manufacture, clinical and preclinical testing, to ensure that it complies with the requirements of the health law, in particular the Royal Decree 192/2023on medical devices.
Depending on the country, the health authorities in charge of registration may vary. For example, in the United States, the agency in charge of this process is the Food and Drug Administration (FDA), while in the European Union, each country has its own regulatory body (in Spain, the AEMPS), although all must comply with the regulations established by the Medical Device Regulation (MDR) or the In Vitro Diagnostic Medical Device Regulation (IVDR).
Registration of medical devices is a procedure by which manufacturers, importers or distributors must obtain approval from the competent health authorities to market their products. This registration involves a detailed evaluation of the product, including its design, manufacture, clinical and preclinical testing, to ensure that it complies with the requirements of the health law, in particular the Royal Decree 192/2023on medical devices.
Depending on the country, the health authorities in charge of registration may vary. For example, in the United States, the agency in charge of this process is the Food and Drug Administration (FDA), while in the European Union, each country has its own regulatory body (in Spain, the AEMPS), although all must comply with the regulations established by the Medical Device Regulation (MDR) or the In Vitro Diagnostic Medical Device Regulation (IVDR).
Importance of medical device registration
In addition to knowing that it is mandatory, it is very important to register medical devices correctly for several reasons. Medical devices affect many more people than drugs, there are devices and software that are used even if the user is not ill, solely for the purpose of preserving health. For this reason, the AEMPS carries out a series of surveillance activities of the products once they are marketed with the purpose of collecting all the incidences and adverse events that could appear related to the device in question. This is particularly important in the case of high-risk medical devices, such as pacemakers or implants, where any failure could have serious consequences for patients.
Second, registration of medical devices also builds confidence among consumers and healthcare professionals. Knowing that a product has been reviewed and approved by a competent authority increases credibility and facilitates market adoption.
In addition, the registration process helps standardize medical devices internationally. Through compliance with global standards, such as those of the International Organization for Standardization (ISO), manufacturers can ensure that their products are accepted in multiple markets, facilitating international expansion and competition in the industry.
Stages in the registration of medical devices
In order to register a medical device correctly, a number of steps must be taken prior to evaluation by the competent authority.
1. Classification
First of all, the product has to be classified according to its risk. All regulations, especially MDR 745/2017 which regulates medical devices marketed in the European Union, offer a classification based on risk. Thus, class I products, are considered low risk, such as bandages or thermometers and usually have a simpler registration process in which the technical documentation is only evaluated by the AEMPS. High-risk products, such as cardiac prostheses or diagnostic imaging equipment, require a more exhaustive evaluation.
1. Classification
First of all, the product has to be classified according to its risk. All regulations, especially MDR 745/2017 which regulates medical devices marketed in the European Union, offer a classification based on risk. Thus, class I products, are considered low risk, such as bandages or thermometers and usually have a simpler registration process in which the technical documentation is only evaluated by the AEMPS. High-risk products, such as cardiac prostheses or diagnostic imaging equipment, require a more exhaustive evaluation.
2. Technical Documentation
Once the product has been classified, the manufacturer must prepare a product dossier (the so called Medical Device File in English). This is technical documentation detailing all product characteristics, design, materials used, manufacturing processes and tests performed, as well as a detailed summary of all clinical evidence supporting the clinical benefits of the product. This documentation must demonstrate that the product meets the safety and efficacy requirements established by the applicable regulations.
2. Technical Documentation
Once the product has been classified, the manufacturer must prepare a product dossier (the so called Medical Device File in English). This is technical documentation detailing all product characteristics, design, materials used, manufacturing processes and tests performed, as well as a detailed summary of all clinical evidence supporting the clinical benefits of the product. This documentation must demonstrate that the product meets the safety and efficacy requirements established by the applicable regulations.
3. Clinical Evaluation
A clinical evaluation is required for all products. This involves testing in controlled environments or clinical studies, clinical investigations, to demonstrate that the product works as intended and is safe for use in patients. These clinical evaluations may be based on equivalent devices or, especially those of higher risk (class III for the regulation that applies in the European Union), on clinical investigations. The results of these evaluations should be included in the technical documentation dossier.
3. Clinical Evaluation
A clinical evaluation is required for all products. This involves testing in controlled environments or clinical studies, clinical investigations, to demonstrate that the product works as intended and is safe for use in patients. These clinical evaluations may be based on equivalent devices or, especially those of higher risk (class III for the regulation that applies in the European Union), on clinical investigations. The results of these evaluations should be included in the technical documentation dossier.
4. Review by the Regulatory Authority or by the Notified Body.
If the device is of medium or high risk class, the technical dossier will be reviewed by a Notified Body. In addition, in Spain, it will be reviewed by the AEMPS, whatever its class. This process may involve a series of audits, inspections of manufacturing facilities, and requests for additional information. The objective is to ensure that all aspects of the product comply with current regulations.
4. Review by the Regulatory Authority or by the Notified Body.
If the device is of medium or high risk class, the technical dossier will be reviewed by a Notified Body. In addition, in Spain, it will be reviewed by the AEMPS, whatever its class. This process may involve a series of audits, inspections of manufacturing facilities, and requests for additional information. The objective is to ensure that all aspects of the product comply with current regulations.
5. Obtaining the Certificate of Conformity
If the product complies with all requirements, the notified body will issue a certificate of conformity or a formal approval that allows the product to be marketed. In the European Union, for example, products that comply with the MDR receive the CE mark, which is mandatory for sale in the European market. In Spain, it is also necessary to obtain a medical device manufacturer’s license, which is granted upon completion of the evaluation of the documentation.
5. Obtaining the Certificate of Conformity
If the product complies with all requirements, the notified body will issue a certificate of conformity or a formal approval that allows the product to be marketed. In the European Union, for example, products that comply with the MDR receive the CE mark, which is mandatory for sale in the European market. In Spain, it is also necessary to obtain a medical device manufacturer’s license, which is granted upon completion of the evaluation of the documentation.
Challenges in the registration of medical devices
Registration of medical devices can be a long and complex process, especially for innovative or high-tech products.
Manufacturers must be prepared to comply with all regulations that apply to them, which may require adaptations in the design or manufacturing process.
In addition, the registration process by the competent authority (the AEMPS in Spain) is costly, both in terms of time and financial resources.
Clinical investigations, their authorization by the AEMPS, the preparation of documentation and audits are activities that require considerable investment, which can be a challenge for small and medium-sized companies.
The registration and process of obtaining a certificate of conformity by medical device manufacturers ensures that only safe and effective products reach the market. It requires planning and is critical to protecting public health. Manufacturers must be well informed and prepared to navigate this process, ensuring that the highest standards of quality and safety are met.