Between mdd and mdr: class i medical devices
Medical devices (MD) can be marketed only if complying with the relevant essential requirements described in annex I of Directive 93/42/EEC (MDD). In compliance with the provisions of annex IX of the above directive, a MD should be assigned with a risk class.
Among all possible classes (I, IIa, IIb and III), class I includes medical devices that are considered at low risk. For such MDs, the intervention of a notified body (NB) in order to obtain the CE marking of the product is not necessary.
Notified bodies are bodies authorised by the Ministry of Health of a Member State of the European Union and/or by the European Commission, applying the conformity assessment procedures and releasing product conformity certificates for the CE marking.
The manufacturer, in compliance with Annex VII, is however bound to draft a declaration of conformity as well as fill in and manage the required technical documentation. The latter shall be stored up to 5 year from the latest manufacturing date of the marketed products.
At the end of these operations, by which the manufacturer ensures the compliance with all the MDD provisions, it’s the manufacturer that applies the CE marking on their own MDs. MDs with measuring functions (Im) and MDs marketed in a sterile condition (Is) are an exception, as they require a certificate released by a Notified Body in any case, in order to be marketed.
As of 25 May 2020, however, the new MDs intended to be marketed in Europe shall comply with the regulation on the medical devices 2017/745 (MDR).
The most significant aspects include the obligation to mechanisms aimed at implementing a unique identification of the device (UDI), along with the obligations, which the manufacturer is obliged to in terms of surveillance and vigilance activities.
In general, the data collection by the manufacturer regarding the marketed medical devices and in service shall be a proactive and continuous activity throughout the lifecycle of the device. The collected data shall be used for a continuous update of the clinical assessment and risk analysis, in order to confirm the conformity to the safety and performance requirements applicable to the device and to detect any critical issue that should be examined as provided for by the risk management plan.
In the first place, however, manufacturers shall check the compliance of the product to the general safety and performance requirements described in Annex I.
The classification procedures are instead reported in annex VIII. These, as per the MDD, takes into account the intended use, duration, invasiveness and the intrinsic risk of the device.
The new legal framework presents manufacturers with different methods to show the conformity with the MDR. Provided that, after the reclassification process, a MD continues to belong to class I, the path to be followed by the manufacturer aims at storing the technical documentation in compliance with annexes II and III.
Moreover, for a Class I device marketed in a sterile condition (Is), with a measuring function (Im) or re-usable surgical instruments (Ir, a class introduced by the MDR), a quality management system (QMS) should be put in place to control the manufacturing or to control special features (e.g. sterility, measurements, re-usable characteristics).
For class Is, Im and Ir devices, a notified body will continue to be involved to control how the QMS manages these functions in relation to the assessment procedure of the selected conformity.
Here is a clarifying block diagram:
In this figure, PMS means Post Market Surveillance, i.e the market surveillance following the marketing of the product. For any further details, please read the document MDCG 2019-15 “Guidance notes for manufacturers of class I Medical Devices”.
Written by: Antonio Ciriello
