When human beings function in full symbiosis with their environment, they are unstoppable.
Crises inspire us to get the best out of ourselves, and the outbreak and reckless spread of COVID-19 made many of us to start vigorously searching for solutions.
The insufficient number of medical devices to alleviate the effects of the virus has provoked the awakening of alternative ideas in COVID-19 response.
Taking advantage of the opportunities brought by the development of new technologies, the concept of having 3D printing and 3D-printed products used in a medical context for COVID-19 is a clear example of the above.
Do you want to know what the EU legal framework governing these contemporary products is? Keep reading, then!
Here below we present a recently published document from the European Commission:
Is there any applicable EU legal framework in the case of 3D printing?
3D Printing, also known as Additive Manufacturing (AM), is a manufacturing process that uses 3D Printers as means of production. Evidently, the range of final products is immense and for different applications.
3D Printers fall under the definition of machinery and subsequently under the scope of the Machinery Directive 2006/42/EC. Therefore, manufacturers must ensure 3D Printers compliance with the essential health and safety requirements of the Directive, compose a technical file and affix the CE-marking before placing them on the EU market.
However, the above does not discard the application of other EU pieces of legislation such as the EMC Directive 2014/30/EC, WEEE Directive 2012/19/EU, RoHS II Directive 2011/65/EU, REACH 1907/2006/EU and Directive (EU) 2017/2102.
3D printed products can become medical devices which would fall within the scope of the MDD 93/42/EEC. If this is the case, manufacturers must ensure that these products meet the requirements of the applicable legislation, and Obelis can always help you to do so. Carrying out a conformity assessment procedure, composing a technical file, drafting the EU declaration of conformity and affixing the CE marking, before placing the products on the EU market, are essential here.
Are there any mandatory EU standards for 3D printers?
The a-priori performance of a risk assessment is essential to determine the applicable health and safety requirements to the 3D Printers, whose design and construction must consider the results of such a risk assessment.
The Machinery Directive provides manufacturers with the possibility of relying on harmonized specific technical solutions. When any of those solutions is chosen, the product concerned is presumed to be in conformity with the health, safety and performance requirements that the harmonized standards aim to cover. Conversely, if the manufacturer chooses to adopt a different technical solution, a detailed explanation on its compliance with the EU requirements is required in the technical file.
The following are the most relevant harmonized standards under the Machinery Directive for laser-based 3D Printers (metal):
- EN ISO 12100
- EN 60204-1
- EN 13849-1
- EN 13850
- EN ISO 11553-1
- EN ISO 19353
You can purchase them all at the website of ISO.
Kindly note that, for plastic printers, fire and explosion standards are relevant too.
Is there any applicable EU legal framework for 3D printed products used in a medical context?
To know the applicable legal acquis, the intended purpose of the 3D printed product is key. Depending on the latter, the product may fall under the definition of medical device or may not. However, there is a nuance to be stressed in here: accessories of medical devices (which are not medical devices on its own), but are intended to be used specifically to enable the use of a medical device, may qualify as medical devices and shall meet the requirements of the applicable legislation. In turn, parts and components are also expected to satisfy the safety requirements of a medical device, being part thereof.
(!) 3D printed plastic valves used in respiratory ventilators may qualify as either accessories or parts and components of medical devices.
While the conformity assessment procedure for medical devices is based on the Manufacturer’s QMS, the following standard may be used:
- EN ISO 13485:2016/AC: 2018
Whereas there are no harmonized standards that specifically apply to additively manufactured parts to be used in the medical devices sector, other standards may be used. Design specifications for specific devices and parts, components or accessories can be obtained through an agreement with an existing medical device manufacturer or through a national competent authority.
Given the importance of ventilators to fight against COVID-19, find below a list of recently published harmonized standards for ventilator parts, components and accessories:
- EN ISO 17510-1:2009 Sleep apnoea breathing therapy – Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007);
- EN ISO 17510-2:2009 Sleep apnoea breathing therapy – Part 2: Masks and application accessories (ISO 17510-2:2007);
- EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators;
- EN ISO 8835-3:2009 Inhalational anaesthesia systems – Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007) EN ISO 8835-3:2009/A1:201);
- EN ISO 5366-1:2009 Anaesthetic and respiratory equipment – Tracheostomy tubes – Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000);
- EN ISO 7376:2009 Anaesthetic and respiratory equipment – Laryngoscopes for tracheal intubation (ISO 7376:2009);
- EN 13544-1:2007+A1:2009 Respiratory therapy equipment – Part 1: Nebulizing systems and their component;
- EN 13544-2:2002+A1:2009 Respiratory therapy equipment – Part 2: Tubing and connectors.
Additionally, note that it is essential that the materials used are safe and performant.
Are there any design specifications available to produce 3D printed products used in ventilators?
3D Printing companies are strongly encouraged to contact an existing medical devices manufacturer and request the design specification required.
Consult the full European Commission document here.
Carlos Francisco Marín Barrios
Regulatory Affairs Department
If you produce 3D-printed products that are qualified as medical devices and are considered as low-risk devices (Class I), contact Obelis to place them on the market immediately! We will guide you through the process, while securing the compliance of your device.