February 2, 2023
By Sarah Mundim and Evangeline Loh
We wrote previously that RDC 751/2022 replaced RDC 185/2001. For 21 long years, RDC No. 185 remained the legislation regarding registration of medical devices in Brazil. Risk classification (Annex II) was included as well as the description of the applicable regulatory regimes, Cadastro (Class I and II devices), and Registro (Class III and IV devices).
RDC 185/2001 Annex II largely comprised the 18 rules from the European Medical Devices Directive MDD 93/42/EEC, Annex IX Classification Criteria; Class I, II, III, and IV in Brazil aligned with European MDD Class I, IIa, IIb, and III.
In the EU, MDD 93/42/EEC, was replaced by the Medical Devices Regulation (MDR) (EU) 2017/745. And, Annex IX was replaced by the new Annex VIII and 22 classification rules. While not a surprise, RDC 751/2022 now incorporates as Annex I the 22 rules from the MDR. Hence, a review of the MDR risk classification changes (from the MDD) is a good preview of what to expect when the new Brazilian regulation becomes effective on March 1, 2023.
For example, Rule 2 now applies to blood bags; Rule 6 now includes central nervous system; and breast implants as well as joint prostheses are added to Rule 8 as Class IV devices. There are few deviations from the MDR, and one of note is that Rule 16 of RDC 751/2022 states that artificial tears and ophthalmic lubricants, when classified as medical devices, would be Class III. In the EU, from the Manual on Borderline and Classification for the MDD, eye drops for lubrication of the eye would likely be Class IIa or IIb according to Rule 5.
While there will be differences in classification between medical devices in the EU and Brazil, for regulatory professionals trying to interpret Annex I of RDC 751/2022, we would recommend as a good starting point review of the European guidance MDCG 2021-24 and the Manual on Borderline and Classification for the MDR.
Sarah Mundim is Senior Quality and Regulatory Affairs Consultant and Evangeline Loh is Global Regulatory Affairs Manager at Emergo by UL.