Common Specifications for products without an intended medical purpose
Amy Eikelenboom
Co-founder of NAALA
Published on 21 January, 2022
By: Amy Eikelenboom – Co-founder of NAALA
Published on 21 January, 2022
The applicability of the European Medical Devices Regulation (hereinafter: “EU MDR”) introduced the applicability of its requirements on devices without an intended medical purpose. The EU MDR lists these devices in its Annex XVI. Why is the EU MDR applicable to these devices? Well, these products are considered to have the same characteristics and risk profile as medical devices and therefore must meet the same general performance and safety requirements.
As these products cover a wide variety of devices intended to be used for different applications, the European Commission has established Common Specifications for risk management and transitional provisions benefitting clinical evaluations. The Common Specifications and the MDR are applicable as of June 22, 2023.
What are Common Specifications?
The EU MDR defines common specifications as the set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a devices, process or system.
The EU MDR lays down so-called general requirements for medical devices to meet. As these leave some room for interpretation, the European Commission publishes harmonized international standards to be used to give substance to these requirements. Where such standards do not exist or are insufficient, the European Commission has another tool in their toolbox they can use: Common Specifications. Common Specifications are meant to define specific criteria that manufacturers must comply with. These criteria are meant to overcome any deficiencies apparent.
What are examples of products without an intended medical purpose?
The Common Specifications have been laid down in an implementing regulation (hereinafter: “Regulation”). Before we dive into what these Common Specifications for risk management and clinical investigations entail, it is useful to understand how the Regulation is structured.
The Common Specifications are specified for sub-category devices without a medical purpose and annexed to the Regulation:
- Annex I: all groups of products without an intended medical purpose;
- Annex II: contact lenses (as specified in that Annex);
- Annex III: products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy, with the exception of tattooing products and piercings (as specified in that Annex);
- Annex IV: substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, such as facial fillers;
- Annex V: equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty;
- Annex VI: high intensity electromagnetic radiation emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment (as specified in that Annex);
- Annex VII: equipment intended for brain stimulation that apply electrical current or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain (as specified in that Annex).
What does the Regulation established with regards to clinical evaluation?
Most devices without an intended medical purpose need to perform a clinical evaluation to demonstrate safety and effectiveness. However, as the EU MDR provisions are new to these product groups, there is no post-market data available and demonstrating equivalence to a medical device is not possible. Therefore, these product types most often need to conduct clinical investigations. In this regard, the Regulation includes transitional arrangements to allow the manufacturers enough time to conduct the required clinical investigations and conformity assessment procedure.
The Regulation describes the conditions that must be met for the transitional provisions to apply, for example, that the product was already lawfully marketed in the Union and that no significant changes in the design and intended purpose of the product are made.
What does the Regulation propose with regard to risk management?
In order to facilitate the implementation of risk management by manufacturers of both medical devices and products without an intended medical purpose, the Regulation describes to base risk management for both groups of products on the same harmonized principles. The rules on the application of risk management should therefore be in line with well-established international guidance in the field, including the international standard ISO 14971:2019.
In order to ensure appropriate risk management, it is necessary to identify specific risk factors to be analyzed and minimized and to identify specific risk control measures to be implemented.
Annex I lists the general risk management requirements applicable to all devices covered by Annexes II to VII. These general requirements follow the risk management activities detailed in ISO 14971, namely:
- Risk management planning;
- Identification of hazards and risk analysis;
- Risk evaluation;
- Risk control and evaluation of residual risks;
- Risk management review;
- Production and post-production activities
The remaining of this article details the specific requirements defined for certain product groups without an intended medical purpose. The complete text of these annexes, can be found here.
This annex lists specific risks to be analyzed and eliminated or reduced as far as possible. These are, for example:
- Risks related to the design and manufacturing or such contact lenses, such as the shape of the device in view of potential irritation, the selection of raw materials for the lenses itself and the storage solutions, biological safety and biocompatibility, microbiological properties, appropriateness of the primary packaging in terms of sterilization and storage conditions.
- Risks related to the distribution chain such as the lack of pre-use testing of suitability of lens wearing performed by professionals and lack of expertise of distributors.
- Risks related to the user, such as lack of experiences, lack of hygiene, any possible factors that could cause deterioration of eye sight, non-medical conditions under which contact lenses are not to be used, risk of eye damage, the effect of duration of use and risks linked to re-use.
The annex furthermore proposes specific risk control measures:
- The field of vision shall not be reduced by the lens;
- All materials shall be biocompatible, non-irritating and non-toxic;
- Lenses and packaging shall be sterile and non-pyrogenic;
- Lenses shall be designed to not compromise the health of the cornea;
- Effective maintenance liquids shall be provided in case of multiple use;
- The manufacturer shall validate the maximum number of re-uses and maximum duration of use;
- The use of eye drops shall be considered;
- A procedure for the identification of any undesirable side-effects shall be established;
- The instructions for use and label shall be designed and written in a manner so that they can be understandable by a lay person and that enables a lay person to use the device safely. The annex lays down some specific topics to be addressed in both the label and the instructions for use.
This annex lists specific aspects to be taken into account, for example:
- The composition of the implant;
- The selection of raw materials in view of biological safety, biocompatibility and chemical and biological additives or contaminants;
- When applicable, indicating the half-life and the end of the resorption;
- Biological safety and biocompatibility;
- Microbiological properties;
- The specific anatomical location;
- Consumer specific factors;
- Potential interactions with magnetic field;
- Use of accessories
- Where applicable, time interval between implantations.
Additionally, the annex lists risks to be analyzed and eliminated or reduced as far as possible. These are, for example:
- Microbiological contamination, presence of manufacturing debris, implantation procedure risks (including use errors), asymmetry, visibility through the skin, and more.
The annex furthermore proposes specific risk control measures:
- Devices shall be sterile and non-pyrogenic;
- The safe use shall be supported by clinical and other data considering the anatomical location;
- Long-term data shall be collected;
- Presence of substances shall be evaluated;
- The provision of trainings to support safe use. To accommodate to this, the annex lists topics to be included on the label and/or in the instructions for use.
This annex lists specific aspects to be taken into account, for example:
- Physical and chemical characteristics of the device;
- The selection of raw materials;
- Biological safety and biocompatibility;
- Resorption and life-time in the body, indicating the half-life and the end of the resorption;
- Microbiological properties;
- Anatomical location;
- Consumer specific factors;
- Risks related to use of local anesthetics, either as part of the product or stand-alone;
- When applicable, the risk associated with the removal of the devices;
- Aspects associated with the use of the devices. The annex also includes specific topics to be included onto the label and in the instructions for use.
Additionally, the annex lists risks to be analyzed and eliminated or reduced as far as possible. These are, for example:
Microbiological contamination, presence of manufacturing debris, risks associated with the procedure to inject, device visibility through the skin, unintended local inflammation and swelling, discomfort or pain, hematoma, infection and inflammation, and more.
The annex furthermore proposes specific risk control measures:
- Devices shall be sterile non-pyrogenic and intended for single use.
- The safe use of the devices shall be supported by clinical and other data considering the anatomical location;
- Long-term data shall be collected;
- Training shall be provided;
- The presence of substances shall be evaluated.
This annex lists specific aspects to be taken into account, for example:
- The volume of tissue which may be removed;
- Minimum time lapse between subsequent procedures;
- Anatomical location;
- The cannula type, for example the diameter and nature of the tip;
- The amount of suction which will be applied;
- The use and subsequent metabolization of infiltrative fluid with a justification for the choice of fluid and its composition;
- The type of liposuction which the device is intended to provide
- Whether the device incorporates any other mechanism of action;
- The age distribution, gender and body-max-index of the intended population;
- The way in which energy is emitted.
As is the case with the previous annexes, this annex also lists information to be provided on the label and in the instructions for use.
Additionally, the annex lists risks to be analyzed and eliminated or reduced as far as possible. These are, for example:
- Post-operative seroma, tissue injury, indirect risks, thermal injury, inflammation and more.
The annex furthermore proposes specific risk control measures:
- Biocompatibility, non-irritating, and non-toxic when used in accordance with the instructions for use;
- Invasive parts shall be sterile and pyrogen-free;
- The device shall have the functions of low energy preset, emergency stop function, automatic deactivation in case of over-exposure or excessive liposuction, respectively;
- Devices shall not be used in private environments by lay persons;
- Training shall be provided to users on safe and effective use of the device.
After you have defined the potential risks, implementation of the ISO 27001 requirements should be used to mitigate these potential risks. In case additional mitigation is still required, ISO 27001 requirements can be supplemented with additional organization specific controls. The implementation of these controls must be done two-fold:
- Firstly, in the design or the organization which means that appropriate policies and procedures should be available within the organization. You could request NAALA’s ISO 27001 toolkit from us which includes all the pre-written policies, procedures and templates your need.
- Secondly, the controls should be implemented in practice. The measures described in the appropriate policies and procedures should be implemented in the organizational ways of working. This starts by making employees aware of the information security risks and mitigating controls implemented.
This annex lists specific aspects to be taken into account, for example:
- Various skin types and the degree of tanning of the skin;
- Age of the customer;
- Possibility of concurrent medical treatments or drug misuse;
- Reduced reaction to harm caused by local or systemic anesthesia;
- Exposure to other light sources
Additionally, the annex lists risks to be analyzed and eliminated or reduced as far as possible. These are, for example:
- Burns, formation of scars and keloids, accelerated aging of skin, blistering, excessive pain, unintended release of radiation, etc.
The annex furthermore proposes specific risk control measures:
- Avoidance of unauthorized access to or unintended use of the devices. This annex also specifies information to be provided on the label and in the instructions for use;
- Display of the characteristics of the emitted optical radiation for the purpose of permanent surveillance and recording of the emission through the device;
- Continuous contact controls and an interlock system ensuring that the device works only in case of full skin contact with the emitting area of the device;
- Avoidance of overexposure for each session of the treatment by particular measures;
- Where applicable, integrated skin tone sensors assessing the skin patch of or near to the area to be treated and allowing emission output only if skin pigmentation is suited for treatment and if there is continuous full skin contact after skin tone analysis;
- Measures to avoid overexposure by repeated treatment sessions or repeated treatments;
- Low energy preset;
- Optimized limitation of pulse duration;
- Optimized limitation of treatment areas;
- Minimisation of scattered radiation;
- Minimisation of the risk of accidental emission;
- Emergency stop function;
- For devices for hair removal: minimisation of ultraviolet radiation;
- Devices intended to deliver permanent change of the appearance shall not be used on persons who are less than 18 years old;
- Information for the user on the correct functioning of the devices and the actual mode of operation by means of acoustic or optical means in standby mode, in operating mode and in case of loss of full skin contact during the procedure;
- Instruction of the user to protect nevi or lesions during the procedure.
This annex lists specific aspects to be taken into account, for example:
- The incorrect placement of electrodes and coils. The annex also lists topics to be included onto the label and in the instructions for use;
- Different neural responses in different groups of persons;
- The presence of active implantable or body-worn medical devices;
- Unforeseen neural effects due to excessive, frequent and cumulative long-term use.
Additionally, the annex lists risks to be analyzed and eliminated or reduced as far as possible. These are, for example:
- Psychological risks, neural and neuro-toxicity risks, short-term, medium-term and long-term cognitive side-effects, etc.
The annex furthermore proposes specific risk control measures:
- The exclusion of the following categories of consumers: persons with a history of epilepsy, persons undergoing pharmaceutical treatment for conditions related to the central nervous system, persons undergoing therapeutic treatment which changes the excitability of the central nervous system, users of illicit substances or other substances that modify a person’s natural perception regardless of whether those are commonly understood as therapeutic drugs, persons who have a tumor in the central nervous system, persons who have vascular, traumatic, infectious or metabolic lesions or disease of the brain, persons who suffer from sleep disorders, drug dependency or alcoholism, persons who are less than 18 years old, pregnant women.
- The application of safety measures.
- Controls related to the application time, the waveform and the energy applied.
Please contact us if you wish additional information on our EU MDR support.
Questions? We are happy to discuss your specific case.
Related
Non-medical purpose products, such as colored contact lenses, lip fillers, and hair or tattoo removal lasers, have gained popularity in recent years. While these products do not have a medical purpose, they can still impact the health and safety of users if not manufactured or used correctly. To address this concern, the European Union (EU) has decided to apply regulations similar to those for medical devices to these non-medical purpose products. In this blog post, we will explore the new EU regulation, effective as of June 22, 2023, and provide insights for manufacturers on compliance and safety.
In this blog post, we explain how IPL and laser equipment are regulated by the Medical Devices Regulation (MDR) and what manufacturers need to do to comply with the new rules.
In this blog post, we explain why facial fillers are considered medical devices under the Medical Devices Regulation (MDR) and what requirements apply to them. We also discuss the challenges and opportunities for manufacturers of facial fillers in the EU market.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only. Changes in legal or regulatory requirements may occur at short notice, which we cannot reflect on a daily basis.