BSI Important update relating to MDCG 2020-12
Guidance on transitional provisions for consultations of authorities on devices incorporating a substance, which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured utilising non-viable animal tissues or derivatives from TSE-susceptible species.
BSI would like to notify you of the above-referenced document; we believe this is of critical importance to ALL legal manufacturers of products impacted by this guidance. We want to draw your attention to three significant impacts on devices:
- Products Certified under Rule 13 of the MDD 93/42/EEC
Legal manufacturers with devices certified under Rule 13 of the MDD will be required to apply to their notified body for a full MDR conformity assessment covering all requirements. A full submission must be completed even if the device is certified under the MDD.
For the first consultation under the MDR, the notified body must submit the full documentation package to the medicinal product's authority as described in the guidance; a supplementary change cannot be submitted. Where the MDD medicinal consultation was completed by the MHRA, a transfer of information to a European Competent Authority will also be required as part of this process.
- Removal of the words "liability to act upon the body" in MDR (EU) 2017/745
MDCG 2020-12 states that any device not under Rule 13 (MDD) according to the “liability to act” justification must now complete a full consultation under the MDR and must, therefore, come under Rule 14 (MDR).
• “It should be noted that Annex I 7.4 of the MDD refers to devices in which the substance is liable to act upon the body. In the MDR (Article 52(9), referring to Article 1(8), and Section 5.2 of Annex IX), this is no longer the case. Therefore, for all those devices where the "liability to act upon the body" was used by the manufacturer as a justification not to follow the consultation, the consultation must take place under the MDR. In those cases where there are doubts on the applicability of the consultation, independently of any considerations concerning the classification of the device, the notified body should seek the scientific opinion as described in Annex IX Section 5.2(b) of the MDR.”
If your device was exempt from Rule 13 under MDD based on an agreed “liability to act” justification, Rule 14 under MDR is likely to apply with additional regulatory and documentation requirements.
- Medical devices and active implantable medical devices within the scope of Regulation (EU) 722/2012
Devices within the scope of Regulation (EU) 722/2012 will be required to apply to their notified body for a full MDR conformity assessment covering all requirements. A full submission must be completed even if the device is already certified under the MDD. For the first consultation under the MDR, the notified body must submit the summary evaluation report (SER) to their coordinating Competent Authority, as described in Annex 5 of Regulation (EU) 722/2012, and the SER will be circulated to the Competent Authorities of all Member States for comment.
Please action urgently to meet the MDR deadline
The transition to the MDR is approaching rapidly, and for clients who fall within the above three categories, this means complete Technical Documentation will need to be submitted to BSI Notified Body. ALL products with devices incorporating a substance which may be considered a medicinal product, and which has action ancillary to that of the device, in addition to devices manufactured utilising non-viable animal tissues or derivatives from TSE-susceptible species, MUST complete a full conformity assessment including a consultation.
Timelines for the consultation section of the review are up to 210 days for medicinal products and up to 12 weeks for animal tissue. These review times are in addition to the notified body review, and therefore you need to URGENTLY submit your application under the MDR to BSI as a Notified Body. The following document outlines the process for an application and highlights the urgency of submitting your completed application to BSI to ensure continuity of supply to the market:
https://page.bsigroup.com/e/73472/app-and-cert-process-uk-en-pdf/t4xts5/951440300?h=afwRjgq1oHaO8oXz232c7g_hyUtl0mu8I1-OX_QiUVc
Please speak with our experienced Medicinal and Biological team via medicinal@bsigroup.com to ensure we can schedule your requirements.
Yours Sincerely,
Dr Jennifer Durrant
Global Head, Medicinal and Biologics Team
Regulatory references:
MDD 93/42/EEC Classification Rules:
Rule 13
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 65/65/EEC, and which is liable to act on the human body with action ancillary to that of the devices, are in Class III.
MDR (EU) 2017/745 Classification, Special rules:
7.1. Rule 14 All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices, are classified as Class III.
Point 2 of Article of 1 Directive 2001/83/EC:
2. Medicinal product: (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
Point 10 of Article 1 of Directive 2001/83/EC:
10. Medicinal products derived from human blood or human plasma: Medicinal products based on blood constituents which are prepared industrially by public or private establishments, such medicinal products including, in particular, albumin, coagulating factors and immunoglobulins of human origin
