We remind you that new of last month is the issuance of the Delegation Law 53 with which the parliament “passes the ball” to the Government for the reception of some European directives, including the MDR. The Government will have 12 months to apply the transposition directives .
The areas of adjustment are: post-marketing surveillance and surveillance, communication between manufacturers and authorities, management by public bodies, sanctioning system, traceability and UDI system, purchase of DM, GDPR and financing system.

Now let’s see what are the main changes with respect to the directive and the obligations that come into force from 26/05/2021.

Let’s start immediately by remembering that in order to guarantee full compliance with the law , an appropriate professional figure must be appointed to take care of supervision of the various business tasks, that are:
• Compliance of devices with the quality system
• Drafting and updating of the technical documentation and the EU declaration of conformity
• Compliance with post-market surveillance and reporting obligations
• Release of the declaration in the event of an investigation into the medical device
This person must be internal to the company, with the exception of micro-enterprises (companies with less than 50 employees and a turnover of less than 10 million euros) which can have an external figure.

The new Regulation adds a new class for reusable surgical instruments, the Ir, and implements a more stringent classification of devices: there are many devices whose risk class has been updated and which consequently must be recertified. Responsible for this task are the Notified Bodies, which under the MDR are in turn subject to the obligation of requalification. According to the old MDD 93/42 directive these were 56, while to date, there are only twenty qualified Bodies.

To allow manufacturers to adapt to certifications, a transitional period has been envisaged. Here are the expiration dates:
• Until 25/05/2021: all certificates issued in accordance with the AIMDD and MDD directives are valid until the expiration date.
• From 05/26/2021 to 05/25/2024: certificates issued in accordance with the AIMDD and MDD directives before the full application of the MDR (05/26/2021) remain valid until 05/24/2024 provided that there are significant changes in the design and intended use.
• Until 25/05/2024: devices that according to MDD were class I, but which under MDR pass to a higher category and therefore require the intervention of a Notified Body, can continue to be placed on the market until that date on condition that there are no MDRs and significant changes in design and intended use. • From 05/26/2024 to 05/27/2025: MDD devices already placed on the market can continue to be made available • From May 2024, all devices placed on the market must be MDR compliant.
In this regard, we remind you that the various stages of supplying a device, from launch on the market to reaching the user, have been defined as follows: • placing on the market: it is the first making available of a device on the Union market;
• provision: is the supply of a device for distribution, consumption or use on the Union market;
• commissioning: phases in which a device has been made available to the end user as it is ready for first use on the Union market according to its intended use.

The new Regulation adds a new class for reusable surgical instruments, the Ir, and implements a more stringent classification of devices: there are many devices whose risk class has been updated and which consequently must be recertified. Responsible for this task are the Notified Bodies, which under the MDR are in turn subject to the obligation of requalification. According to the old MDD 93/42 directive these were 56, while to date, there are only twenty qualified Bodies.

Another novelty with respect to the MDD is the new declaration of conformity, the mandatory document certifying compliance with EU requirements, which with the MDR is enriched with information.

Particular attention was paid to the MDR regarding the identification and traceability of medical devices. In fact, 10 articles have been foreseen in this regard (art. 25 – 34). The focal point is the UDI code, the new Unique Identification Code, whose purpose is to identify and track the device with absolute certainty.
The obligation to affix the code on the label of the DM started on:
• 26/05/2021 for implantable and Class III devices
• 26/05/2023 for Class IIa and IIb devices
• 26/05/2025 for Class I devices

Direct marking on reusable devices is mandatory from:
• 26/05/2023 for implantable and Class III devices
• 26/05/2025 for Class IIa and IIb devices
• 26/05/2027 for Class I devices

Post-market surveillance is becoming more stringent, manufacturers are now required to plan, establish, document, implement, maintain and update a post-market surveillance system for each device, in order to collect, record and analyze quality data. , on the performance and safety of the device during its entire life. This system will have to be based on a post-market surveillance plan. Consequently, manufacturers are required to draw up a post-market surveillance report for Class I devices and a PSUR for Class IIa, IIb and III devices.

Another important revision has been given to the area of clinical evaluation and clinical investigations: the MDR requires manufacturers to carry out a systematic and continuous clinical evaluation for each medical device on the market and to prepare clinical investigations in the event of gaps in clinical evidence. of products, obligations already foreseen in the MDD, but now more detailed and filled with some gaps.

Key figure of the MDR is EUDAMED, the European database of medical devices, consisting of six modules:

• Registration of the plaintiff (manufacturer, authorized representative, importer and distributor)
• UDI and device registration
• Registration of economic operators
• Notified and certified bodies
• Clinical investigations and performance studies
• Supervision and post-marketing surveillance

The new EUDAMED database, the aim of which is to improve general transparency and strengthen coordination between different Member States in the EU, will only be available from May 2022.

Finally, we recall that in April the Delegation Law no. 53 was issued with which the parliament “passes the ball” to the Government for the reception of some European directives, including the MDR itself. The Government will have 12 months to apply the transposition directives. The areas of adjustment are: post-marketing surveillance and surveillance, communication between manufacturers and authorities, management by public bodies, sanctioning system, traceability and UDI system, purchase of DM, GDPR and financing system.