On May 26, 2021, the EU Regulation 2017/746 (Medical Device Regulation – MDR) came into force, which entails a profound change in the discipline of the production and marketing of medical devices.
The new Regulation arose from the need to revise the three regulations issued in the 1990s, i.e. Dir. 90/385 / CEE, Dir. 93/42 / CEE and Dir. 98/79 / CEE to respond to the regulatory needs deriving from the important and extremely innovative technological advances made over the last twenty years in terms of extremely innovative medical devices.
Currently, several transitional arrangements are in place until 2025.
As can be seen from the EU website, “The regulation on medical devices aims to guarantee a high level of public health and patient safety, taking into account scientific progress” and is integrated by the regulation on in vitro diagnostic medical devices whose application is scheduled for 2022.
In short, the new regulation will involve changes to the general qualifications of the products, more stringent quality requirements, better traceability and audits, together with greater control of the certification institutes.
- New law: what it entails
- The new regulation includes:
- All medical devices and their accessories
Some cosmetic products such as colored contact lenses or cosmetic implant devices and materials. Devices designed for the “prediction and prognosis” of a disease or other health condition.
A new classification of some devices is also provided and UDI coding (i.e. Unique Device Identification – unique identification of devices) has been introduced to allow for better traceability and facilitate the possible withdrawal of devices that present a security risk.
Broadly speaking, the MDR aims to
improve the quality and safety of medical devices by strengthening the way in which they are evaluated and certified before their introduction on the market; make the data used for approvals more transparent; improve post-marketing surveillance; reduce administrative burdens for producers.
All this will entail new responsibilities, further obligations to investigate technical documentation and a more rigorous system of both clinical evaluation and post-sales surveillance for the economic operators involved in the medical device market.
Classification of medical devices
The regulation maintains the classification of medical devices divided into four risk classes, namely: I, IIA, IIB, III depending on the intended use and the risks it entails. The classification depends on the intended use indicated by the manufacturer:
Class I – Low-risk devices: products for external patient help (i.e .: crutches or wheelchairs, stethoscopes, etc.) that do not require the intervention of a Notified Body (with the exception of sterile devices and / or with measurement function) and must be registered with the relevant local authorities.
Classes IIa and IIb – Medium risk devices: many electro-medical devices fall into these classes.
Class III – High risk devices, such as cardiovascular catheters. In addition, the Software as an active device also falls into this category; that is, it is considered a medical device when it is intended to provide information that can be used to make decisions for diagnostic or therapeutic purposes.
- Class IIa, IIb and III devices require the intervention of a Notified Body.
- Novelty compared to the past
- It should be noted that, compared to the past, the MDR introduces:
New classification rules and changes some rules of the MDD (Medical Device Directive), making the classification criteria more rigorous (ref. Annex XVIII of the MDR). In addition, a different conformity assessment procedure is envisaged – based on the product risk class – before the product can be placed on the EU market.
Establishment of an EU-wide database on medical devices (EUDAMED – (European Databank for Medical Devices), supported by a new device identification system based on a unique device identifier (UDI). It will make available within large data sets in the field of medical devices.
Introduction of the new figure, i.e. “Person Responsible for Compliance with Regulations” (PRRN), appointed by manufacturers and authorized representatives. It has the task of carrying out an internal check on compliance with the regulations by the manufacturer or the authorized representative and, if necessary, report any non-compliance to the same.
The figures of economic operators such as Manufacturer, Distributor, Agent and Importer are better defined in terms of responsibilities and obligations and related specific obligations.
The Manufacturer must have