The European Union has worked against the clock to provide Member States with the possibility of manufacturing their own medical supplies.
The European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), have published a list of European standards, drawn up in accordance with ISO standards, relating to certain medical devices. This measure gives a boost and support to those companies that wish to start the manufacture of sanitary products. These standards also they help to market them more easily in the internal market, with the guarantees that this implies.
What European reference standard, we highlight the REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 5, 2017 on medical devices. Amending Directive 2001/83 / EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Directives 90/385 / EEC and 93/42 / Council CEE. The rest of the European and national standards in relation to the sector will depend on it.
European legislation on medical devices and personal protective equipment is based on harmonized standards.
For the manufacture of medical devices, such as their commercialization both in Europe and in Spain, the related regulations must be complied with.
TO Spain the following set of rules applies to you that indicate the validation process to be followed by the masks and the medical devices manufactured, among which we highlight those that concern us in this matter:
EN 149: 2009 Respiratory protection devices. Filtering half masks for protection against particles.
EN ISO 10993-1: 2009 Biological evaluation of medical devices.
EN 14683: 2019 Medical face shields.
EN 14126: 2003 Protective clothing.
EN 14605: 2009 Protective clothing against liquid chemicals.
EN 13795-1: 2019 Surgical drapes and gowns.
EN 13795-2: 2019 Clean air drapes, gowns and suits for surgical use as a medical device, for patients, clinical staff and equipment.
EN ISO 13688: 2013 Protective clothing.
At the level of national regulations, we highlight:
- The Spanish Association for Standardization (UNE). Its specifications provide manufacturers with the necessary requirements in the manufacture of medical devices, having to comply with its specifications to obtain a product with an optimal level of efficiency.
- AC: 2019 on surgical masks. Requirements and test methods
- UNE EN 149: 2001 + A1: 2010 on Respiratory protection devices. Filtering half masks for protection against particles. Requirements, tests, marking.
Both UNE and the Ministries of Industry, Commerce and Tourism and the Ministry of Consumption They have produced guides for both manufacturers and consumers that clarify manufacturing issues.
- Implementing Decision (EU) 2020/437 of the Commission of March 24, 2020 on the harmonized standards applicable to medical devices prepared in support of Council Directive 93/42 / EEC.
- Resolution of March 20, 2020, of the General Secretariat for Industry and Small and Medium Enterprises, on alternative specifications to PPE masks with European CE marking.
- Order SND / 326/2020, of April 6, by which special measures are established for the granting of prior licenses for the operation of facilities and for the commissioning of certain medical devices without CE marking on the occasion of the health crisis caused by COVID-19.
Once the regulatory framework of the regulations on products and health protection has been defined, we detail the validation processes that the manufacture of Spanish masks has to go through.
Regarding the actions prior to manufacturing:
- Ensure that medical devices have been manufactured in accordance with the above requirements.
- Prepare the technical documentation regarding compliance with the essential requirements and affix the CE marking to the product.
- The evaluation procedures based on the category of medical device that it is.
- Carry out the evaluation process by checking tests.
The company that has the appropriate means to pass the indicated tests and the quality system appropriate to the evaluation procedure that ensure compliance with the essential requirements of the Directive can, once validated that your product complies with each and every one of the requirements, Make the Declaration of Conformity and mark your products with the CE marking.
Each manufacturer is responsible for declaring compliance with the established requirements or to make it available to a third party with the power to declare said conformity.
Companies that will manufacture sanitary products They need a Prior Operating License granted by the Spanish Agency for Health Products Medicines (AEMPS), in accordance with Royal Decree 1591/2009, of October 16.
Regarding the production process, the manufacturer must maintain clean conditions to ensure a low microbial level. They should use TNT materials that comply with UNE-EN 1644-1: 1997 on Test methods for non-woven fabric pads for medical use.
Are sanitary products manufactured in Spain reliable?
Given all the justification on the previous normative basis, Spanish standards are supported by European Directives. Hierarchically superior regulation general to each of the Member States once transposed. At the same time, Spanish development regulations are endorsed by bodies of recognized prestige in the regulatory field such as the UNE.
HeiQ Medica not only complies with Spanish and European regulations, but is also awarded for its scientific and research work. HeiQ is a pioneer and leader in the field of intelligent technology applied to the textile sector, to develop its sanitary products.
It has an exclusive unique manufacturing process that includes:
- An additional impregnation at the end of the process with HeiQ Viroblock technology, which grants properties antibacterial, anti microbes and anti germs. This quality makes the great difference with respect to its national and international competitors.
- Machines used in manufacturing are equipped with unique ultrasonic welding systems for assembly. Ideal process according to the regulations: it must be heat sealed and not sewn.
- Its specialized machines make it possible to optimize manufacturing times and costs, having a direct impact on the quality guarantee and final price of the product.