European Regulatory Issues with Custom Made Medical Devices

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The world of medical 3D printing gives surgeons tools that they never had before. The new technology translates into less surgical time, minimally invasive procedure, and geometries that were impossible to reproduce until now. Patients indeed benefit a lot from this new solution. However, having the abilities to make new 3D-printed devices doesn’t mean that we should ignore a patient’s safety:

One reason is that 3D-printed implants often do not come from the medical devices industry. The second reason is that the regulatory entities are not ready for the number of new companies appearing in this market.

The European Union considers 3D-printed implants a custom-made medical device under the old 93/42/CE Directive (MDD 93/24/CE). However, the new Medical Device Regulation MDR (EU) 2017/745 states that 3D printed implants are not considered custom made medical devices under the CE mark. It also says that these devices should still follow all the directives according to their risk classification.

Classification of medical devices determines the level of risk of each medical device. The classes are class I, class IIA, class IIB, and classIII. Implantable medical devices are considered class IIB and class III, depending on the time of implantation and if the device will create modifications or release drugs. A bone substitute was considered as class IIB previously, but they were forced to change to class III because they were resorbable, and this would cause changes in the body.

Because of the reasons mentioned before, not having the CE mark doesn’t mean 3D-printed implantable medical devices shouldn’t follow the regulation for Class IIB or class III devices. The scandal involving the PIP silicone implants is very recent, and we don’t want that to happen with 3D-printed medical devices and create distrust from patients to these solutions.

European regulation for medical device follow several ISO’s:

ISO 13485, which specifies requirements for a quality management system (QMS), where an organization with the ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of a 3D-printed implant life-cycle, including design, development, production, storage, distribution, installation, and servicing of a medical device, and more.

ISO 11737-1:2018 sterilization of health care products:

Microbiological methods — Part 1: Determination of a population of microorganisms on products. This specifies requirements and guides the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material, or package.

ISO 11737 – 2009 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process. This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

ISO 11607- 2019 regulates the packaging for terminally sterilized medical devices part I: requirements for materials, sterile barrier systems and packaging systems, shelf life.

It is common to see some of the 3D-printed implants being sterilized in an autoclave. However, an autoclave is not an authorized sterilization system for an implantable medical device.

Health professionals should know more about patient safety when talking about medical devices to understand some of the complications that could occur after implantation.

3D printed implants open new problems during the manufacturing of medical devices because until now, the product was already certified by the supplier. 3D printing implant companies should develop GMP (good management practices) to avoid contamination of the product. Such GMP includes dedicated machines, clean rooms, and consistent internal analysis to ensure the purity of the core of the device. Cleaning of the surface should be done in dedicated cleanrooms, and analysis should confirm your process has no biological or physical contamination. Finally, using certified blisters and controlled sterilization either by ETO or gamma radiation.

Boneeasy has one ISO 6 cleanroom dedicated to titanium 3D-printing, where we have our metal printers, and the powder is completely processed inside of this room. We have an ISO 6 cleanroom for cleaning the devices. We also have an ISO 4 cleanroom where we do packaging. In addition, we have a quality control process for our metal implants, including spectrophotometry for the core and SEM and EDS for the surface. Testings on bioburden, sterilization, ETO residues, and endotoxins are outsourced to certified laboratories.

In conclusion, 3D-printed implantable medical devices are new options that help surgeons with more accurate surgeries and improve the quality of life of the patients. However, the manufacturers should comply with the regulation, and countries should go further on with more specific rules for 3D-printed custom made medical devices.

About the Author:

Rui Coelho

I’ve started as a DDS, jumping almost immediately to maxillofacial surgery, I’ve taught dental implantology at the University from 1993 to 1998, a post-graduate program. From 2011 I’ve dedicated to the Industry as a project manager for some projects including “Digital stratification of dental crowns”. The project was developing a 5-axes 3D printer to make stratification of dental crowns with composites by 3D printing.

In 2013 I’ve found two companies “Tailoredimplant” and “Boneeasy”, the first was to develop 3D software for surgeons designing bone grafts and the second one a bioprinting company that prints implantable medical devices.

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