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Thursday, 03 December 2020 11:43

Implications of the new MDR (EU 2017/745) for Class I medical devices Featured

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Víctor Javier Primo Capella2,1, Rafael Mengual Ortolá1, Laura Martínez Gómez1, José Luis Peris Serra1,2, Ignacio Bermejo Bosch1,2 , David Garrido Jaén1, José Montero Vilela1, Celia Montaner Murgui1, Carlos Atienza Vicente1,2

(1) Instituto de Biomecánica (IBV) Universitat Politècnica de València (Edificio 9C) Camino de Vera s/n (E-46022) Valencia (Spain)

(2) IBV Health Technology group, Bioengineering, Biomaterials and Nanomedicine CIBER (BBN CIBER)

 

The period of transition for Class I medical devices to the new regulatory framework established by EU Regulation 2017/745 on medical devices, also known as MDR, will come to an end on 25 May 2021. As of this date, if they wish to continue marketing these products, all manufacturers and their respective products must adapt to the MDR.
This article will address the main changes introduced by the new regulatory framework and will provide the keys to a successful transition for class I medical device manufacturers.

INTRODUCTION

Following a long and complex legislative process, in May 2017, the European Parliament and Council passed EU Regulation 2017/745 on medical devices, also known as MDR (Medical Devices Regulation), which will take the place of former directives 90/385/EEC and 93/42/EEC on active and non-active medical devices.

This new MDR is the biggest regulatory change in the medical device sector in over 25 years.

Why this change? The European institutions that promoted the regulatory change identified three main reasons for this change:

1. The technological advances that have taken place over the last 20 years. The rapid advance of science and the use of new design and manufacturing technologies have meant that the regulatory framework has often been well behind the technological advances.

2. Health scandals such as the one involving the PIP prosthesis (the Poly Implant Prothèse). Everyone will have heard about the PIP breast implant scandal, which not only affected the manufacturer but also the Notified Body in charge of the product’s EC certification. 

3. Deficiencies detected by relevant actors in the sector. Enquiries carried out by the European Union among manufacturers, distributors, Notified Bodies (NB), etc., revealed shortcomings and deficiencies that compromised the main objectives of the former medical device Directives, the safety of such devices, and their free circulation in the internal market.

What objective has the European Union set itself?

The main objective of the changes introduced by the MDR is to guarantee a high level of patient safety and protection, essentially by tightening requirements relating to the demonstration of the safety and performance of medical devices.

Apart from that, the intention is to ensure that the market works properly, by exerting a greater control on the wide variety of devices that are marketed within the European Union, and also by establishing a regulatory framework that favors innovation and the competitiveness of the European medical device industry.

Image of a wheelchair test

MAIN CHANGES INTRODUCED BY THE MDR FOR CLASS I PRODUCT MANUFACTURERS

The innovations introduced by the MDR affect all actors related to the medical device sector: manufacturers, distributors, importers and notified bodies.

In the case of manufacturers, the impact will depend not only on the characteristics of the manufacturer and the state of the implementation of the directives in their processes and procedures, but also on the type of products they manufacture (classification), import and/or market.

Regarding the main changes introduced by the MDR, the following are most relevant to Class I manufacturers:

1. Changes in the classification rules for medical devices: Generally speaking, a series of changes have been introduced in the classification of all types of products. One of the main changes, with special impact on class I devices, is the one introduced by rule 11 regarding software for medical use. According to this rule, computer programs that assist or help in a diagnosis are no longer considered class I, rather they are now considered as at least Class IIa. All manufacturers must justify the class of their product following the rules established by the MDR.

2. Pre-marketing guarantees: The MDR introduces reinforcements in the regulation regarding risk products by means of the scrutiny of conformity assessment, and by demanding more clinical information in the technical file. On the one hand, changes have been introduced in the clinical evaluation of products, which must be carried out by manufacturers independently of the product classification, including Class I products. The clinical evaluation of Class I products will have to be demonstrated through tests and technical-scientific literature. Manufacturers of Class I products will also have to update their documents on the assessment of general safety and performance requirements and on risk analysis. Lastly, the information that must be included on labels, instructions for use, and the Declaration of Conformity has been modified.

3. Post-marketing guarantees: The MDR comprehensively reinforces product post-marketing monitoring systems. All manufacturers, regardless of the classification of their products, must have a post-marketing monitoring system in place that must contain information on the safety and performance of their devices.

4. Increased transparency and traceability: The MDR foresees the creation of European registers of economic operators (manufacturers, authorized representatives and importers) and products. In addition, a unique device identification system (UDI) is being introduced, which will allow for greater control and traceability of products marketed in the EU. All manufacturers must obtain their UDI codes and register the products and actors (distributors) with EUDAMED.

5. Extension of the obligations of economic operators: Manufacturers must have a quality management system in place in which all the processes involved in the life cycle of a medical device must be implemented.

Apart from this, a new figure has been created, the Person Responsible for regulatory compliance, who, as can be inferred from the title, will be the person responsible for ensuring compliance with all the obligations introduced by the MDR.

WHAT DEADLINES ARE SET BY THE MDR?

The MDR came into effect on 26 May 2017, following its approval and subsequent publication. As of this date, directives and regulations have coexisted until its date of implementation, which was the 26th of May 2020. This was the date set for the application of the new regulation for class I products WITHOUT special characteristics (those that DO NOT have measuring functions, those that ARE NOT sterile and those that ARE NOT reusable surgical instruments).

In view of the dramatic emergency situation experienced in 2020 as the result of the pandemic caused by the 2019 coronavirus disease (COVID-19), the different European agencies agreed to 2019 coronavirus disease all MDR application dates for one year, which means that in the case of class I products, the actual application date was moved back to 26 May 2021, thus helping manufacturers to adapt their products to the new regulatory framework.

KEYS FOR CORRECTLY ADAPTING MY CLASS I DEVICES TO THE MDR?

As mentioned above, the impact of adaptation to the MDR will depend on the company’s starting point, the typology and classification of the products, and their state of their documentation. As a company, the manufacturer must realistically assess the regulatory situation of their portfolio to evaluate what its shortcomings and needs are insofar as MDR requirements are concerned. This involves a thorough analysis and in-depth knowledge of the requirements described in the new regulation, and an analysis of the company’s ability to address them.

In those cases where the manufacturer has a large amount of references or product families, it is extremely important that they establish an adaptation strategy which allows them to optimize both the economic cost of adaptation (obtaining UDI codes or carrying out verification tests) and the cost in terms of time and personnel resources.

From a product point of view, the guide provided by the European Commission is a good starting point for the implementation of the MDR. The adaptation process described in it is applicable to all the manufacturer’s products and product families.

However, given the complexity of the approved regulatory framework, many companies resort to expert advice, not only for the actual adaptation of the technical files, but also to define the best possible way to carry out that adaptation. The Instituto de Biomecánica (IBV), in its desire to support the medical device sector, makes all its experience and knowledge available to manufacturers, in order to accompany them throughout the process of developing and assessing their products and of adapting them to the new MDR regulation, not limited to medical devices of Class I but also to devices of Class IIa, IIb and even Class III.

Read 560 times Last modified on Thursday, 03 December 2020 12:36



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