Since of 26th of May 2021, the Medical Device Regulation (MDR) came into effect.
The IVDR (In Vitro Diagnostic medical devices Regulation) will repeal the existing IVD Directive (98/79/EC)
on 26th of May 2022.
This Regulation is significant, and leads to a new approach in the European regulatory framework - the very fact that the directive is turned into a regulation makes it significant in such a way that it will no longer be possible to add further requirements in each country beyond the directive since the regulation applies to the entire European Union which is hierarchically above the individual countries. The new regulation began to take form in 2012, was finally approved in May 2017 (it took five years to formulate and approve it!), and three years were given before it would officially come into effect.
May 2020 was the scheduled date, but due to the global COVID-19 crisis, it was postponed by a year and set for May 2021. A grace period of five years was set before the full enforcement of the new regulation; however, we are currently awaiting the publication of the EU report following the postponement, and it seems organizations will have to comply with MDR as soon as the three-year period elapses.
What exactly are the significant changes between the existing directive and the new regulation?
Let's start with the fact that today there are three different directives that regulate medical devices in Europe, which has led to certain countries introducing additional requirements for the placing of Medical Devices in their territories (such as national registrations). The regulation is, by definition, applied equally across the European Union, and no longer allows for individual interpretation in each country.
Apart from that, the regulation introduces the following new rules and requirements:
High-risk products are required to face much stricter quality control and audit.
A new system for approving and supervising Notified Bodies.
Clear procedures for the certification process (frequency of each test, audit plan, clear content).
Inclusion of products without a medical purpose.
New classification rules
Transparency of information to the general public.
Evaluation of up-to-date clinical information (for all types of a medical device - also Class I).
NEW obligations on importers and distributors located in Europe
Designation of the person responsible for the regulation in the country of manufacture (PRRC).
Collaborations between health authorities.
It is important to understand that the new regulation has come about in order to strengthen the weak links and resolve the issues that have been identified since the application of the Directives in the late 1990s’, mainly in three areas: new technologies (such as medical- aesthetics products, software, etc.), traceability of events and products and public transparency.
What should be done to prepare for the NEW requirements?
STEP 1 - Classification
To comply with the new requirements, manufacturers must first establish the classification of their devices, according to the new classification rules, and act accordingly. It is important to note that there are products that are currently at a low-risk level (Class I) but might become a medium-risk level (IIa) or high-risk level (Class III) under the new regulation. For example, software or surgical gloves that are currently classified today as Class I, but under the new regulation, they will be classified as Class IIa or III (!).
STEP 2 - Identification
manufacturers must figure out what the new regulation means in terms of product approval and what is relevant to your specific device. It is advisable to run a gap analysis in order to update the technical portfolio, quality system, evaluation, and clinical plan, and even address cases where there is an overlap between the new regulation MDR and other regulations, such as the GDPR.
STEP 3 – Technical Documentation
Once we have mapped the requirements, understood the classification, coordinated expectations with the notified body or an authorized representative in the EU – we can start modifying the technical documentation (Technical File) and quality management system (although the manufacturer is required to present a quality management system under the new regulation, the recommendation is to apply ISO 13485:2016 version, mostly since it’s the acceptable standard for quality system management, but also because it is "best" evidence to show compliance with the quality management system requirements.
STEP 4 – Notified Body & Authorized Representative
Once all these have been compiled and reviewed, the manufacturer must contact a Notified Body and a European Authorized Representative in order to certify the medical device under the MDR and complete the EUDAMED registration.
STEP 5 – CE Marking & EUDAMED
One of the main objectives of the MDR was to offer transparency to the general public. To this end, a European database EUDAMED (European Database of Medical Device) has been set up, into which data will be entered on a regular basis. This will include clinical data, clinical investigations, incidents, and reports. In addition, the manufacturer is required to submit to the authorities an annual report detailing the manufacturer's activity and the medical Device PSUR (= Periodic safety update reports), in order to increase transparency.
There is no doubt that the transition between the existing directives and the new regulation may prove revolutionary, although there are undoubtedly still some unanswered questions. The EU is determined to meet the set deadlines and bring the new regulation into effect in May 2021.
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