Medical devices: MDCG 2021-24 guidance on classification has been published
From the 4th October 2021 on the European Commission website can be found the MDCG 2021-24; the guideline uses the same format as the MEDDEV 2.4/1 rev.9 drawn up under Dir. 93/42/EEC. The MDCG 2021-24 has been drawn up by the homonymous team of experts “MDCG” (Medical Device Coordination Group) and provides important theoric references and practical examples to manufacturers in order to help them carrying out the medical device classification under Reg. 2017/745(EU) and s.m.i.
The guideline, 57 pages long, is divided into 4 chapters:
- Purpose of the medical device classification;
- Practical relevance of classification;
- How to carry out classification;
- Handling of interpretational problems.
The first chapter of the MDCG 2021-24 highlights how the classification rules referred to in the Annex VIII of the Regulation 2017/745 (EU) and s.m.i. are mostly based on those laid down in the Global Harmonization guideline GHTF/SG1/N77:2012 of the 2nd November 2012, that nowadays can be consulted on the IMDRF website. The whole system is risk-based and takes into account the vulnerability of the human body and the potential risks associated with the devices.
Exactly like the previous regulatory regime, the european approach to medical device classification relies on a set of criteria that can be combined in various ways; you can find below a non-exaustive list:
- duration of contact with the body;
- degree of invasiveness;
- local vs. systemic effect;
- potential toxicity;
- part of the body affected by the use of the device;
- the device depends on a source of energy or not.
The guideline reminds that, even before applying the classification rules, it is of primary importance for the manufacturer to assess if the product falls within the scope of the Reg. 2017/745 (EU) and s.m.i. as medical device, accessory of a medical device, medical device part or component for replacement or as a device without an intended medical purpose listed in Annex XVI.
The risk classes of the devices according to Article 51 of the Regulation are not affected by substantial changes in regard to those established by the Dir. 93/42/EEC and s.m.i., as they remain, in increasing risk order, class I, class IIa, class IIb and class III. Moreover, some class I subclasses have been introduced (Article 52.7 paragraphs a, b and c) and their conformity assessment procedure involves – even if to a limited extent- a notified body:
- Is (class I sterile devices);
- Im (class I devices with measurement function);
- Ir (class I reusable surgical instruments).
It is important to mention that the MDCG 2021-24 contains in some of its paragraphs several definitions; among these we can find “locally dispersed”. This subject is in fact mentioned in the discussed “Special rule 21”, although the text of the Regulation does not provide its definition. Worth noticing also the definitions of “systemic absorption”, “derivative” and “wholly or mainly absorbed”.
In addition, the MDCG 2021-24 shows, in its chapter 4.1, four flow diagrams that cover all the classification rules laid down in the chapter III of the Annex VIII of the Regulation. The diagrams cover, in sequence, non-invasive devices, invasive devices, active devices and special rules.
It is also worth noticing how the MDCG 2021-24 handles the interpretational problems (chapter 3.3) in a different way when compared to the MEDDEV 2.4/1 rev.9. In fact, as soon as a notified body needs to be involved, the Competent Authority of the Member State in which the manufacturer or its authorized representative has its registered place of business is required to take a decision, instead of the Competent Authority to which the notified body is subject. Where the notified body concerned is established in a Member State other than that of the manufacturer, the Competent Authority must adopt its decision after consultation with the Competent Authority of the Member State that designated the notified body.
Written by: Riccardo Del Signore
Foto di Bruno /Germany da Pixabay
