Devices without a medical purpose are excluded from the scope of the Medical Device and Active Implantable Medical Device Directives, however a group of such products are now regulated in the Medical Device Regulation 2017/745 due for application on 26 May 2021. The rationale behind their inclusion is based upon potential unreasonable risks these device types may impart upon use. The legislation applies to these products regardless of whether the point of use is at home by the end consumer or in a healthcare professional setting.
List of product groups WITHOUT an intended medical purpose now within scope of MDR:
Products under scope of Annex XVI do not need to comply with the MDR until the common specifications (CS) for the respective product types have been adopted and published by the Commission. This publication is envisaged as being not later than 26 May 2021. Adherence to the CS will be mandatory for manufacturers 6 months from date of issue or from 26 May 2021 (whichever is earlier). Note, according to the MDR implementation rolling plan, these CS were due Q4 2020, the Commission may not meet this deadline as they remain in the planning stage. Until the CS are published, individual Member States’ national qualification of products described in Annex XVI will remain in force.
Common specifications (CS) refer to technical and/or clinical requirements (other than a standard), that provide a means of complying with the legal obligations applicable to the device. It is anticipated that the CS for Annex XVI products will take into account existing harmonised standards which apply to analogous medical devices. These new CS will at a minimum, incorporate requirements for risk management and may even include clinical evaluation for assessing safety.
Overall execution of compliance for these devices must take into account the state of the art, and in particular, existing standards for comparable devices with a medical purpose, based on similar technology. Even if not yet required to comply with the MDR, Annex XVI product manufacturers need to prepare NOW for compliance:
- assign risk classification
- comply with Common Specifications
- have an authorised representative in the EU, if the manufacturer is outside the EU
- conformity assessment
- maintain technical documentation including declaration of conformity;
- affix CE marking
- assign a unique device identifier (UDI) and submit data to EUDAMED
- submit Economic Operator information to Eudamed
- appoint a person responsible for regulatory compliance
- maintain a quality management system
- post-market surveillance and vigilance requirements, including field safety corrective actions and reporting serious incidents to the competent authority
- monitor compliance for organisations in the supply chain e.g. distributors
- maintain insurance against potential product liability.
Additionally, there are mandatory requirements for manufacturers to provide consumers with certain information, an example – implant cards for those receiving implantable devices, such as dermal fillers.
Do not exhale a sigh of relief if your non-medical device product does not currently fall under the regulation. The EC will continue to monitor for any risks identified and failure of safe performance of this product class, thus possibly (probably) adding additional device descriptions under the scope of MDR Annex XVI.
And, do not forget about United Kingdom and Switzerland……
For the manufacturers of these devices, it will no longer be a case of “sell them and forget them”.
If you are a manufacturer of an Annex XVI device destined for or already marketed in Europe and are struggling to cope, please get in touch.