Question for written answer E-002392/2021
to the Commission
Rule 138
Patrizia Toia (S&D), Simona Bonafè (S&D), Antonio Tajani (PPE), Maria da Graça Carvalho (PPE), Claudia Gamon (Renew)
Subject: Implementation of the Medical Devices and In Vitro Diagnostics Regulations
The date of application of the Medical Devices(1) and In Vitro Diagnostics(2) Regulations is fast approaching. Key implementing tools are still pending and some developments seem to go against what was agreed by the legislators during the adoption negotiations. In particular, it appears that the ongoing revision of the medical devices guidance document(3) introduces changes to the long‑standing guidance that was known to Parliament at the time of the negotiations preceding the actual text.
The scope of the regulation cannot be modified without the involvement of Parliament. It is common practice for Member States to fully comply with guidance documents when applying the scope in the legislation, even if it is not legally binding.
1. Did the Commission consider making Parliament aware of these potential changes and ensuring that the legislators’ will is respected in the final version of those guidance documents?
2. Will the Commission guarantee that any change introduced will not modify the scope of the regulations?
(1) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
(2) https://eur-lex.europa.eu/eli/reg/2017/746/oj
(3) https://ec.europa.eu/docsroom/documents/10328/attachments/1/translations