Clarification of the scope of the Medical Devices Regulation for tissues and cells products
New EU regulations for medical devices (MDR) and in-vitro medical devices (IVDR) have been introduced. These regulations entered into force on 25 May 2017 across EU Member States. However, most requirements will not fully apply until 26 May 2020 for the MDR, and 26 May 2022 for the IVDR.
The scope of the MDR now includes certain products manufactured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered non-viable. The following information clarifies the regulatory classification of non-viable tissue and cell products and their derivatives and the HTA’s remit with respect to these products.
Further information on the Regulations can be found on the MHRA website.
Medical device regulation (MDR) and what it covers
The scope of the MDR now covers devices manufactured using derivatives of tissues or cells of human origin that are either:
- non-viable; or
- are rendered non-viable.
This falls in line with the definitions of the terms ‘device’ and ‘derivative’ under the MDR. Full definitions can be found in Article 2(1) of the MDR.
Non-viable tissues and cells themselves will not fall within the scope of the MDR.
For example derivatives of non-viable tissues and cells such collagen fillers (i.e. collagen extracted from tissues and cells) fall under the MDR.
Non-viable tissue and cell products such as demineralised bone matrix (i.e. bone from which inorganic minerals are removed), or acellular human tissues or tissue matrices, will not be covered by the MDR. They will continue to fall under the EUTCD (Directive 2004/23/EC on tissues and cells) and be regulated by the HTA.
The regulation of tissue and cell products under the EUTCD or as a medical device
If the action of tissues or cells or their derivatives is principal and not supplementary to that of the device, and the product does not fall under ATMP regulations (Regulation (EC) No 1394/2007), the EUTCD will apply. These products will be regulated by the HTA but the relevant general safety and performance requirements set out in Annex I of the MDR will apply as far as the safety and performance of the device part are concerned
Any device which includes, as an integral part, non-viable tissues or cells or their derivatives, and that has an additional function to that of the device will be assessed and authorised under the new MDR. In these cases, the provisions for donation, procurement and testing under the EUTCD will still apply to the incorporated tissues and cells.