Medical Surgical Devices (MSD)

MSD, regulated in Italy by Presidential Decree no. 392/1998 and the provision of 5 February 1999, include disinfectants, insecticides, rodenticides, rat poisons and repellents for civil and domestic use. In order to be produced and marketed, they must obtain specific authorization from the Ministry of Health.

Biocidal products

Biocides are EU-regulated by Regulation (EU) no. 528/2012 (BPR). They include a wide range of products intended for the protection of humans, animals, materials and articles, acting on harmful organisms through specific active ingredients. An example of a biocidal product is a disinfectant intended for the sanitization of hospital surfaces.

Regulations and transition from MSD to biocides

The introduction of the BPR Regulation started a process of regulatory harmonization in EU Member States. This regulation aims at simplifying the procedures for the authorization and approval of active substances, introducing uniform standards to ensure high levels of safety and environmental protection. The transition from MSD to biocides is a challenge for manufacturing companies, which must adapt to new rules and prepare complete dossiers for the authorization of each product by the date of approval of the active substance contained.

In Italy, a transitional regime that allows Member States to apply national legislation up to three years after the approval of the active substances (or in any case until the authorization of the biocidal product by the competent authority) is foreseen. During this period, MSD containing approved active substances can be marketed, but with limitations that vary depending on the specificity of the product.

Types of Biocides

The BPR classifies biocides into four main groups:

1. Disinfectants and general biocides (for surfaces, drinking water and textiles).
2. Preservatives (for food, cosmetics, and building materials).
3. Control of harmful organisms (such as insecticides, rodenticides and repellent products).
4. Other specific biocides (including treatments for specialized materials and surfaces).

Each group is divided into “product types” (PT), which identify the context in which the biocidal product is used. For example, PT2 refers to disinfectants not intended for direct application to humans and animals, while PT4 refers to disinfectants for surfaces in contact with food.

Implications for companies. Companies producing MSDs (in particular, biocides) face significant challenges in complying with European regulations.

• Preparation of authorization dossiers: The Biocidal Products Regulation requires manufacturers to provide detailed data on the safety and efficacy of the product, as well as information on risks to humans and the environment.
• Analytical compliance: Chemical-physical tests, stability studies, and efficacy tests must comply with the requirements of the Biocidal Products Regulation, as well as the quality regime.
• Reduction of animal testing: The regulation promotes alternative methods for testing biocides, reducing the use of animal models.

Importance of Biocides

Biocides play a crucial role in protecting against infections and diseases, ensuring hygiene and safety in various areas.

• Healthcare: Disinfectants for hospital facilities and clinics.
• Veterinary: Products for the hygiene of animals, shelters and means of transport intended for them
• Industrial and domestic: Solutions for the sanitization of surfaces, environments and materials.

Their use must be balanced to minimize risks to human health and the environment. Strict regulation helps ensure that only the safest and most effective products are placed on the market.

Regulation

The Biocidal Products Regulation is designed to harmonize the rules for market placement and use of biocidal products. Regulation (EU) no. 528/2012 (Biocidal Products Regulation) defines a common system for all Member States, to ensure safety for human health, animal health and the environment, without hindering the free movement of biocidal products in the internal market.

The Biocidal Products Regulation applies to all active substances and biocidal products used for the control of harmful organisms, including bacteria, viruses, fungi, insects and rodents. This regulation is a significant advance over the Biocidal Products Directive no. 98/8/EC, introducing more stringent measures for risk assessment and promoting safer and more sustainable alternatives.

Authorization of Biocidal Products. The authorization of a biocidal product is a rigorous process involving several steps:

1. Approval of the active substance. This phase takes place at European level and involves the detailed assessment of the safety of the substance for both humans and the environment.
2. Authorization of the biocidal product. After approval of the active substance, the product must be authorized through one of the following procedures:
   • National authorization, valid for a single Member State.
   • Centralized authorization, allowing marketing in all EU Member States.

Reduction of animal testing. The Biocidal Products Regulation encourages the use of alternative methods for safety assessment, minimizing the need for animal testing. Companies must share data to avoid duplication, thus contributing to greater sustainability.

Transition from MSD to biocides

In Italy, MSDs are regulated by national legislation, namely Presidential Decree no. 392/1998. Currently, however, some aspects refer to the Biocides Regulation. MSDs can be authorized only if they contain active substances under review; when an active substance under review is approved, the MSDs must be converted into biocides in order to be marketed, following the authorization procedures established by the Biocidal Products Regulation. During this transition, there is a temporary regime that allows Member States to apply national regulations for a maximum period of three years from the date of approval of the active substance or in any case until the authorization of the biocidal product by the competent authority).

Challenges for companies. Regulatory compliance is a challenge for manufacturers, who must manage:

• The complexity of the documentation required for registration dossiers.
• The high costs of the required analyses and tests.
• The need to constantly update formulations to comply with evolving regulations.