3D printen medische hulpmiddelen volgens richtlijnen Europese Commissie
De Europese Commissie heeft eind maart richtlijnen gepubliceerd om fabrikanten te helpen de productie van essentiële medische uitrusting en materialen verder op te voeren. Het gaat daarbij om de productie van maskers en andere persoonlijke beschermingsmiddelen, handreinigers die niet worden afgespoeld en ontsmettingsmiddelen voor de handen en 3D-printen in de context van het coronavirus. Een richtlijn betreffende medische hulpmiddelen volgt nog.
De documenten hebben tevens tot doel fabrikanten en markttoezichtautoriteiten te helpen ervoor te zorgen dat deze producten aan de nodige veiligheidsnormen voldoen en doeltreffend zijn. In de mededeling worden op drie fronten richtlijnen voorgesteld, waarbij de derde richtlijn is gericht op 3D printen.
De derde richtlijn bevat aanbevelingen voor conformiteitsbeoordelingsprocedures voor 3D printen en 3D geprinte producten voor medisch gebruik in de context van de uitbraak van het coronavirus. In het document wordt ingegaan op de toepasselijke EU-wetgeving voor deze producten en worden voorbeelden gegeven van technische normen die de fabrikanten kunnen gebruiken zodat zij producten in de EU in de handel brengen die aan de voorschriften voldoen.
De Europese Commissie plaatst veelgestelde vragen en antwoorden om de productie van veilige medische uitrusting verder op te voeren.
Een deel van deze vragen en antwoorden (Engels):
3. Is there any applicable EU legal framework for 3D printed products used in a medical context?
Depending on the intended purpose of the 3D printed product, they may qualify as medical devices, or accessories according to the definitions set out in the medical devices legislation. Such products must fullfil all applicable requirements of Directive 93/42/EEC.
In particular, accessories of medical devices (which are not in themselves medical devices), but are intended by the manufacturer to be used specifically to enable the use of a medical device, may qualify as devices and shall meet the requirements of the medical devices legislation. This is not necessarily the case for parts and components of medical devices, which don’t have regulatory status under the Medical Devices Directive 93/42/EEC, however are nonetheless expected to satisfy the safety requirements of a medical device, being part thereof.
For example, 3D printed plastic valves used in respiratory ventilators may qualify as either accessories of medical devices or their parts and components.
Where the conformity assessment procedure for the medical device is based on the Manufacturers’ Quality Management System, the following harmonized standard may be used:
EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/AC:2018
According to such standard, the manufacturer should validate the production process as set out in section 7.5.6 EN ISO 13485:2016. Among other requirements, the validation procedure should also include the equipment qualification.
Harmonised standards on additively manufactured parts to be used in the medical devices sector.
- There are no harmonised standards that specifically apply to additively manufactured parts machine/process used to be used in the medical devices sector. However, other standards may be usedfor their production.
- Existing safety standards related to the manufacturing and use of the specific part/component in the medical devices sector are applicable regardless of the type of machine/process used for their production.
- It is important to choose the correct materials to develop the needed parts or components (e.g. in the case of ventilator valves, compatibility testing between the material and the enriched oxygen fluid to be administered, should be performed)
- It is important to apply appropriate post-processes (e.g. cleaning, sterilisation, biological evaluation) to the manufactured part to ensure the absence of loose powder particles and any other potentially harming elements.
- Other specific requirements laid down in the EU legislation on medical devices are addressed by standards, such as standards on the information to be supplied by the manufacturer, on medical electrical equipment, etc.
- Other than harmonised standards, design specifications for specific devices and device parts, components or accessories can be acquired either through an agreement with an existing medical device manufacturer or though contacting a national competent authority.
List of a recently published list of harmonised standards under the Medical Devices Directive relevant 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
Issues related to the material used
It is essential that the material used for 3D printing are safe and performant and are tested for the purpose of the 3D printed product and its final use. e.g. Thermal Resistance, Mechanical Resistance, Chemical resistance, Resistance to Sterilization.
4. Are there any design specifications available to produce 3D printed products used in ventilators?
- In order for 3D printing companies to manufacture parts, components or accessories of medical devices, they should get into contact with an existing medical devices manufacturer and request the design specification required. These specifications will lay out the technical designs and requirements for the product. For example, to manufacture ventilator valves, it would be crucial to have access to the file of the design in order to know the dimensional characteristic, material to use and tolerances required.
- It should also be noted that every time a new product is intended to be 3D printed, the qualification of the concerned printing process should be updated. This is necessary to confirm that as a result of using the printer, the correct geometry of the 3D printed product is achieved. In addition, the process parameters for the subsequent mass production of such 3D products should be identified and confirmed.
5. Can a 3D printed product falling within the scope of the Medical Devices Directive be placed on the market by virtue of a declaration of conformity?
As above in Q3, this depends on whether or not the product in question can be qualified as a medical device. Where the product qualifies as a medical device, and is a low-risk device (e.g. Class I), then it can be placed on the market through a declaration of conformity issued either by the manufacturer or the authorised representative.