Are you prepared?
As of April 2017, the Council of Ministers and the European Parliament, have adopted a new medical device regulation which also applies to personal/ intimate lubricants. There is a transition period of three (3) years before the new law comes in full effect, i.e., from April 2017 until May 2020.
Personal lubricants with the intent to be used as a personal/sexual lubricant with a medical claim, may only be placed on the European market as a Class IIa medical devices.
At the moment for example a Declaration of Conformity already could be sufficient, but with the more stringent new regulations more will be expected from the distributors and/or companies that distribute their private label branded lubricant. Cobeco can assist their clients with information what needs to be done to comply with the new regulations.
What changes precisely?
There are a few things that change with these regulatory changes of Medical Devices.
1. Classification of medical devices
Medical devices are categorised in 4 major risk classes: Class I medical devices which are devices that have no contact with the human body or have transient (short) contact with the undamaged skin. Class IIa medical devices are products that come in direct contact with a natural body orifice (opening) or damaged skin; Class IIb and Class III are high-risk products such as implants.
Personal lubricants with a medical claim are, however, Class IIa medical devices due to their direct contact with a body orifice (opening) or mucus membrane for a period of <24 hours continuous contact.
2. Conformity assessment process
Each risk class for a medical device is linked to a specific conformity assessment route by which the medical device is CE-marked.
Class I medical devices are self-certified by the legal manufacturer, are notified to the relevant national competent authority and fall under the direct supervision of that national competent authority who can assess the technical documentation to ensure that the dossier meets compliance with the relevant medical device requirements.
Medical devices in Classes IIa, IIb and III require a notified body to be involved in the conformity assessment process. The notified body assesses the technical documentation which the manufacturer has prepared and submitted for assessment and the quality system which the legal manufacturer is required to have in place.
Further, ingredients used in the formulation of the personal lubricants must meet purity levels such as defined in the monographs of the European Pharmacopeia. The legal manufacturer, additionally, is obligated to have sufficient scientific data, which is documented in the technical documentation. Class IIa medical devices also need to comply with specific labelling requirements. These obligations help ensure that personal lubricants meet the highest level of safety and quality.
Essential to the CE-marking, the notified body must conduct a conformity assessment of the technical documentation against the safety requirements stipulated in the medical device regulations and conduct an on-site audit of the manufacturer’s quality system. When the manufacturer passes both aspects of the conformity assessment process, the notified body issues the manufacturer with a CE-certificate of conformity. The approval stipulates that the number of the notified body is included next to or under the CE-mark on the labelling. When the number of the notified body is present with the CE-mark, it is an indication that the product and manufacturer meet regulatory requirements for the class of medical devices indicated by the product.
3. Quality system requirements for medical devices to EN ISO 13485:2016
Medical devices are designed and produced under the conditions set out in a good manufacturing requirements stipulated in a medical device quality system standard. The current standard EN ISO 13485:2012 is valid until March 2019, at which time it will be replaced with EN ISO 13485:2016. As of March 2019, manufacturers of medical devices must comply with the 2016 versions of the standard, which better guarantees the safety of processes and products.
4. Changes in regulatory requirements between Directive and Regulation medical devices
Aside from the new quality system standard, a new medical device regulation is also coming into place. Currently, until May 2020, the medical device Directive 93/42/EEC is still valid. From May 2020, legal manufacturers of medical devices must comply with the Medical device Regulation 2017/745 which was published in April 2017. The Regulation tightens the medical device requirements, including giving the quality system requirements a legal impetus. Further, the new law also defines obligations for distributors and importers of medical devices including compliance with quality system and regulatory medical device requirements.
How can a Class IIa medical device be identified?
An approved Class IIa medical device is identified on its labelling by the CE-mark accompanied by the number of the notified body. Personal lubricants with a medical claim that are intended to be used as personal/intimate sexual lubricants, identified by a CE without a number are Class I medical devices.
Can it be verified whether my product complies with the medical device requirements?
As the medical device regulation and requirements are pan-European in nature, they apply to any and all personal lubricants on the European Union market. The national competent authorities of the member states of the Union, conduct market surveillance and enforce the requirements. Hereby, after May 2020, only personal lubricants with a medical claim which have undergone a Class IIa conformity assessment process are permitted to be placed on the market.
When a manufacturer or a product does not meet the regulatory requirements, the national competent authorities regard this as an infringement. The authorities can require these products to be removed from the market and/or can impose necessary penalties including substantial fines. Serious infringements of the medical device requirements can, for instance, include making false claims about the product, incorrectly CE-marking the products or incorrectly classifying the products.
Important therefore are the following:
What can Cobeco do for you?
Cobeco is specialized in manufacturing private label branded products and has a high expertise in manufacturing lubricants.
In the course of 2019, Cobeco will supply CE-marked Class IIa personal lubricants to the (European) market. We started our process for adapting our ISO and technical file long ago, so we can ensure to provide our clients with manufactured lubricants to comply with the new and more stringent regulations. Cobeco ensures that our clients will be able to transfer their private labelling brands we produce for them in a timely manner to market the device as a Class IIa device. We would be pleased to support their activities and provide with all necessary information to make their adaptions to the distributors obligations.
Cobeco has a number of solutions available for different scenarios to ensure a timely transfer is implemented that will support our clients activities; and will be pleased to provide them with a bespoke proposal.