[co-author: Vicky Vlontzou]
In light of the challenges posed by the COVID-19 pandemic to the usual channels of manufacture and distribution of medical devices, healthcare institutions have begun to manufacture medical devices and their accessories and to reprocess used medical devices. On 9 April 2020, the Belgian Federal Agency of Medicines and Health Products (AFMPS) issued a Circular providing the framework for collaboration between healthcare institutions and external companies intended to address the existing shortages in essential materials.
The intended purpose of the Circular is to establish the conditions and the means with which healthcare institutions may respond to emergency shortages of essential materials either, through manufacturing medical devices or, by subcontracting the manufacture and reprocessing of medical devices to third parties.
The Circular applies to medical devices, in vitro diagnostic medical devices and related accessories that are regulated by the Directive on Medical Devices 93/42/EEC (MDD), and the Directive on In Vitro Medical Devices 98/79/EEC (IVDD), the Medical Devices Regulation 74/2017 (EU) (MDR) and the In Vitro Medical Devices Regulation 746/2017 (EU) (IVDR). Active implantable devices falling within the scope of the Medical Devices Regulation are excluded from the scope of the Circular.
“In house” manufacture of medical devices
The Circular provides that healthcare institutions may request assistance from third parties to carry out the design, manufacture, packaging and labeling of the medical devices that fall within its scope. The Circular provides that such devices shall be considered to be “in house” devices. An “in house” device may only be used in a healthcare institution and cannot be placed on the market.
An “in house” device must, moreover, fulfill the following requirements:
- It must be exclusively used during the COVID-19 crisis situation from 13 March 2020 until the end date that will be defined by the AFMPS;
- The original medical device or CE marked alternative devices must no longer be available to the healthcare institution within the crucial time frame for the treatment of the patient;
- The subcontracting company responsible for manufacture of the medical device must prefill the related notification document declaring the ISO standards or their equivalents with which the company's quality systems, risk management systems, and the systems in place for the biocompatibility of the materials used comply;
- The subcontracting party must ensure the validation of the batched produced by keeping a list of healthcare establishments to which it has provided the medical devices as well as a list of suppliers that provided the raw materials used in their production;
- The system of vigilance that has been established within healthcare institutions in accordance with Royal Decree of 15 November 2017 must cover the medical devices manufactured within the context of the Circular;
- Healthcare institutions must keep a record of all patient samples tested with a specific batch of an in vitro diagnostic medical device;
- For medical devices that must be sterilized before use, the choice of the material used as well as the design of the device must take account of the sterilization methods used in the healthcare institution;
- The healthcare institution and the subcontractors must send a related notification to the AFMPS by email to email@example.com with the subject line “in-house initiative COVID-19”.
Reprocessing of single-use medical devices
The Circular provides that certain medical devices labelled as single-use may be reused provided certain related requirements are fulfilled. The reprocessing may be carried out either by health institutions themselves or by a trusted subcontractor subject to the following conditions:
- The devices must be reprocessed only during the COVID-19 crisis situation;
- The original medical device or CE marked alternative devices must be unavailable;
- Single-use medical devices that are reprocessed by an external company at the request of a healthcare institution must be returned to the institution in their entirety;
- The AFMPS must be notified of the activity by the healthcare establishment or the subcontractor by email to firstname.lastname@example.org with the subject line “notification of reprocessing activity in the context of COVID-19 outbreak”.