Laser and IPL devices, dermal filler applicators, fat reduction systems, skin removal products or contact lenses without vision correction: beauty medicine devices and products operate in a demanding regulatory environment today. Since MDR 2017/745 came into force, many of them fall under Annex XVI and are therefore subject to the same requirements as traditional medical devices, even if they do not have a medical purpose.
At the same time, there are products in the field of aesthetic and cosmetic applications for which the regulatory classification is not clear at first glance. Is it a medical device? An Annex XVI product? A cosmetic or technical product outside the MDR? Or can the classification change in the course of development?
For manufacturers, brand owners, start-ups and distributors, this means that if you want to be successful in this market, you need a manufacturing partner who not only produces, but also thinks about the regulatory requirements, technical framework conditions and possible classification issues from the outset.
This is precisely our approach at Mechatronic.
What distinguishes Annex XVI products from other devices
Annex XVI of the MDR defines six product groups that fall under the full regulatory scope of the Medical Device Regulation despite not having a medical purpose. These include laser and IPL devices for skin treatment, devices for liposuction, lipolysis and lipoplasty, dermal fillers and injectable substances for volume and contouring, skin ablation and skin treatment systems, contact lenses without vision correction and cosmetic implants.
What they have in common is that they all require CE marking, a quality management system certified in accordance with ISO 13485, complete technical documentation, risk management in accordance with ISO 14971 and, in many cases, the involvement of a notified body. The requirements are high, the tolerance for documentation gaps is low, and the market is being watched increasingly closely by the authorities.
This is precisely why early classification is crucial. We also support clients when it is not yet clear whether a product is a medical device, an Annex XVI product or a non-medical beauty product. Together, we look at the product idea, intended purpose, technical implementation, planned marketing and regulatory requirements and thus create a reliable basis for the next steps.
Anyone who develops or manufactures here must be able to rely on their partner.
Production that grows with the requirements
Mechatronic manufactures Annex XVI devices and selected beauty products in a controlled production environment designed to meet demanding technical and regulatory requirements. Our quality management system is certified to EN ISO 13485 and our processes are documented, traceable and auditable. This is not a matter of course in contract manufacturing, for us it is the basis.
We do not see production as an isolated step at the end of a long development chain. We get involved at an early stage, accompany the transition to series production, think through production processes from the outset and ensure that what has been developed can also be produced in a reproducible, efficient and standard-compliant manner.
Our range of services extends from prototype construction to very small quantities and large-scale production. We take on complete production processes, but can also map individual sub-areas: Component production, assembly, service, maintenance, repair or production transfer. The result is exactly the support that suits the product, the development phase and the internal set-up of our customers.
New product introduction, production transfer, life cycle management, service and repair are all interlinked because products are not static and markets change.
Who we manufacture for
You have a product, a brand and a market, but no manufacturing infrastructure of your own. We take over the manufacture of your devices or beauty products in a controlled and, if necessary, MDR-compliant environment. We supply you with finished, documented and CE-compliant units that you can place on the market. The responsibilities between the contract manufacturer and the responsible person are clearly defined in our contracts.
Not every product in the beauty, aesthetics or wellness sector can be clearly categorized immediately. We support you in gaining a better understanding of the initial regulatory situation and deriving the consequences in terms of production technology. This is particularly valuable if you have already developed a product, would like to have a product manufactured or are still in the concept phase and want to know which requirements could become relevant in the future.
The path from development to series production is one of the biggest hurdles for many young companies. We are familiar with this transition and provide structured support: from prototype construction to initial sample approval and process validation through to ongoing production. We bring with us the manufacturing and regulatory experience that is often not yet available internally in early company phases.
Capacity expansion, cost pressure, strategic realignment: there are many good reasons to outsource production. A production transfer to Mechatronic does not mean a loss of quality, but a controlled transition to an environment that operates at the same regulatory level as your previous process, often higher.
It is not always necessary to outsource the entire production process. Many customers require targeted support for individual assemblies, assembly processes, service, maintenance or repairs. Here too, we create reliable, documented and scalable processes that can be seamlessly integrated into existing structures.
What sets us apart as a manufacturing partner
Mechatronic is not just a contract manufacturer. We are part of the BAYOONET Group with in-depth MedTech expertise, several locations in Germany and an interdisciplinary team of mechanics, electronics, software and regulatory affairs. This breadth makes the difference: if a question arises in production that points back to development, approval or technical documentation, we can solve it without having to go through external loops.
Our production is Made in Germany, not just as a designation of origin, but as a promise of quality. Short communication channels, high process stability, complete documentation and quality management with real substance ensure that even complex products can be safely transferred to production.
We remain flexible: we manufacture prototypes, small batches, very small quantities and large series. We take on complete devices or individual assemblies. We provide support for new products as well as for existing products that require service, repair, maintenance or production transfer.
From prototype to series production: our process
Your added value: production reliability in a regulated environment
Having Annex XVI devices manufactured in an unsuitable environment is not a calculable risk, it is a structural problem. Regulatory complaints, recalls and loss of the CE market can be possible consequences. With Mechatronic as your manufacturing partner, you close this gap: You get products that not only work, but also fit the requirements of the European market.
And even if your product is not a medical device, you benefit from our quality standards. Because controlled processes, clean documentation, scalable production and technical precision are not only an advantage in a regulated environment, but wherever products need to be manufactured reliably, reproducibly and professionally.
When requirements change, when quantities grow or when a prototype becomes a series product, we are already on board.
Are you planning to manufacture an Appendix XVI device or beauty product?
Get in touch with us. We will give you an initial assessment of manufacturability, process requirements, regulatory classification and the realistic path from product idea to series production. Whether prototype, small series, large series, assembly, service or complete production: We support you exactly where you need us.