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VDE

2024-02-29 expert contribution

The EU Medical Device Regulation (MDR): What is changing?

The requirements of the MDR are extensive. This article explains what manufacturers of medical devices have to deal with.

The European Medical Devices Regulation, (EU) 2017/745 (MDR), replaces the Medical Devices Directive (93/42/EWG, MDD) and Active Implantable Medical Devices Directive (90/385/EWG, AIMDD). The MDR entered into force in 2017. The effective date of the MDR was May 26, 2021, and the MDR transitional provisions will continue until December 31, 2028. This article provides an overview of the main changes introduced by the MDR and the current status of implementation.

What is the current status of MDR implementation?

The practical implementation of the MDR requirements by manufacturers is in full swing. It is clear that the requirements are considerable and in need of interpretation. A number of aspects, such as the rules for risk classification, the acquisition of meaningful clinical data or the practical implementation of post-market surveillance requirements are regularly subject to controversial discussions.

The situation is complicated by the fact that a number of prerequisites have not yet been fully established. These are in particular:

Notified bodies: The professional community assumes that the number of Notified Bodies according to MDR does not cover the needs of the manufacturers. In addition, not all Notified Bodies cover the entire technical spectrum. In view of the recertification of existing products, which will become due when the transitional provisions expire, a considerable bottleneck can be assumed. The EU Commission has recognized this problem and sees the risk of a shortage of medical devices if manufacturers are not allowed to continue marketing their products after the expiration of the legacy certificates. Therefore, the EU Commission has postponed the end of the transition period from May 26, 2024, to Dec. 31, 2026, for implantable Class III custom devices, Dec. 31, 2027, for Class III and certain implantable IIb devices, and Dec. 31, 2028, for all other devices. However, some conditions have to be met in terms of Notified Bodies to be involved. The so-called sell-off deadline of 26.05.2025 has been dropped.
Legal acts: The MDR refers to approximately 50 legal acts that are intended to regulate individual provisions in more detail. At this stage, only a few legal acts have been issued by the EU Commission.
Harmonized standards: These help implement process and product requirements of the MDR and trigger a presumption of conformity when applied appropriately. However, only a few standards have been harmonized by the EU Commission to date. Here you will find the current status of harmonized standards.
Guidances: The EU Commission has established the European Medical Device Coordination Group (MDCG) with the aim of explaining and interpreting the MDR in view of the difficulties of interpretation. Even though new MDCG Guidances are continuously published, explanations on a large number of aspects are still missing. In addition, the overall practicality of the MDCG Guidances appears to be in need of improvement and their application is not mandatory. In any case, the volume of documents to be read and interpreted is constantly increasing.
Eudamed: The European medical device database Eudamed is the basis for a large number of registration obligations. The database is not yet fully functional and is considered complicated to use. Due to the central role of the database, this leads to considerable delays and, in some cases, additional work.

The above-mentioned aspects as well as the large number of documents in terms of laws, rules, or recommendations lead to the fact that the professional circles wrestle over interpretations of terms, definitions and delimitations. Smaller companies in particular find it difficult to implement the documentation effort in practice and to refinance it on the market. As a result, there is a risk that a number of medical devices and medical technology companies will leave the market.

What changes have been made to the MDR so far?

Prior to the effective date of the MDR on May 26, 2021, the MDR was corrected and amended. Corrections were made on May 3, 2019, Dec. 27, 2019, and July 8, 2021, and an amendment to the MDR was made on April 23, 2020. The amendments with the most noticeable impact were the adjustments to the transitional provisions and the postponement of the MDR effective date. The wording of these changes, which requires explanation, and the impact on a variety of other deadlines have resulted in complicated and sometimes difficult-to-understand transitional provisions of the MDR. The history of changes to the MDR can be traced in detail using the consolidated version of the MDR.

What are the main changes of the MDR?

Compared to the EU Directives, the MDR contains additional requirements. No requirements have been deleted. There are the following significant changes:

The MDR has a broader scope and explicitly includes all devices for cleaning, sterilization or disinfection of other medical devices, reprocessed single-use medical devices and certain devices without a medical purpose.
The MDR requires a safety approach that is based on the entire product life cycle and supported by clinical data.
The MDR places more stringent requirements on Notified Bodies.
The MDR introduces consultation by an independent expert panel in the clinical evaluation of certain high-risk products.
The MDR introduces a system for identifying and tracing devices (UDI - Unique Device Identifier).
The MDR requires the entry of extensive data into the Eudamed database.
The MDR imposes requirements on the distribution of medical devices via the Internet or their distance selling.

How has the scope changed?

The scope of application of the MDR has expanded (Article 1). Manufacturers must review their product portfolio to determine whether additional products fall within the scope of the MDR.

Article 1 also lists products that do not fall within the scope of the MDR. This applies, for example, to in vitro diagnostic devices. These medical devices are regulated by a separate EU regulation, the IVDR, (EU)2017/746. Another prominent example is medicinal products.

In addition, Annex XVI contains a list of products whose intended use is not medical, but which nevertheless fall within the scope of the MDR. Examples are contact lenses or devices for fat removal.

Special rules apply to products that combine a medical device with an in vitro diagnostic or a medicinal product. In the case of a combination with a drug, the manufacturer must differentiate in particular the extent to which the device and the drug belong together and what function the drug component has with regard to the overall effect. Accordingly, the regulatory classification is based on either medical device or drug regulations.

In addition, the MDR now clearly states that devices and services sold online fall within the scope of this regulation (Article 6).

What definitions and duties have changed in the MDR?

Overall, the MDR includes a number of amended and new definitions of terms. Important examples in Article 2 are:

the definition of a medical device,
the unique device identifier (UDI),
clinical data,
clinical evidence and
serious incident.

Article 10 of the MDR requires manufacturers to, among other things,

to have a risk management system,
have a quality management system,
conduct a clinical evaluation,
to prepare technical documentation,
and to apply a conformity assessment procedure.

Manufacturers are also responsible for their medical devices once they are on the market. To this end, they must, among other things, designate a "Person Responsible for Regulatory Compliance" (PRRC) who is responsible for compliance (Article 15). Manufacturers of an implantable device must provide an implant identification card to patients (Article 18).

Once they have fulfilled all these obligations, manufacturers draw up an EU declaration of conformity (Article 19) and put the CE conformity marking on their devices (Article 20). Manufacturers who are not established in an EU member state appoint an authorized representative. The MDR details the obligations of authorized representatives (Article 11), importers (Article 13) and distributors (Article 14).

What are the changes in risk classification?

Manufacturers must classify their products into classes I, IIa, IIb and III, taking into account their intended purpose and the associated risks. The risk classes are necessary for the further steps of CE marking, in particular for the choice of the conformity assessment procedure and for the scope of the clinical evaluation. Annex VIII contains 22 classification rules. These have become significantly more stringent. Manufacturers should address the following classification rules in particular:

Rules 5 - 8: invasive devices, surgically invasive devices and implantable devices.
Rules 9 - 13: active products
Rule 11: software
Rule 18: products using tissues and cells
Rule 19: products containing nanomaterials; and
Rule 21: products that consist of substances.

What is changing for Notified Bodies?

The requirements for Notified Bodies have increased considerably (Chapter IV). They must meet significantly stricter criteria, particularly with regard to the existence of clinical competence.

Suitable organizations must apply for designation to a respective competent authority. The process of designation involves assessors from different national and European authorities. Notification is a legal act whereby a Member State informs the Commission and the other Member States that a compliant organization has been designated to carry out conformity assessment according to the Directive.

Manufacturers must check which Notified Body can be considered for a particular product. The EU's Nando database lists all Notified Bodies. Manufacturers must work with a Notified Body to plan the certification process for their product portfolio. Essential questions concern the availability and technical suitability of a Notified Body, the need for data on products and the concretization of the requirements from the MDR.

What is the Unique Device Identification (UDI)?

The MDR introduces a system for unique device identification (UDI). The aim is to improve the identification (Article 27) and traceability (Article 25) of medical devices. Accordingly, each medical device must have a UDI. This consists of 2 parts:

a product-specific identifier (UDI-DI) to identify the product and manufacturer, and
a manufacturing identifier (UDI-PI) to identify the manufacturing unit.

Manufacturers are responsible for entering all UDI-related data into the European medical device database EUDAMED. This contains the UDI database. Manufacturers must keep all UDI related data up to date at all times.

What are the changes in conformity assessment?

The conformity assessment procedure of a device depends on the risk class and specific device characteristics (Article 52, Annexes IX, X and XI). The manufacturer must involve a Notified Body for Class IIa, IIb and III devices. In addition, there are some Class I devices, but with limited procedures. These are:

Devices placed on the market in a sterile condition,
devices with measuring function and
reusable surgical instruments

In addition, there is a new consultation procedure for clinical evaluation for certain class IIb and III devices. For this purpose, an independent panel of experts is to be involved on the basis of the assessment report of the notified body (Article 54).

The MDR also specifies in detail the essential safety and performance requirements in Annex I. The same applies to the structure of the technical documentation in Annexes II and III. Manufacturers must start the clinical evaluation with a clinical evaluation plan (Annex XIV). In addition, the EU Commission reserves the right to adopt "common specifications" as implementing acts (Article 9). These may lead to additional requirements for manufacturers.

What are the requirements of the MDR for clinical evaluation?

The MDR significantly tightens the requirements for clinical evaluation (Article 61). As before, a manufacturer must analyze and evaluate clinical literature data and, if necessary, conduct clinical trials to demonstrate the safety and benefit of a product. However, manufacturers can now rely on comparative data ("equivalence data") only in certain cases, as the new MDR rules are stricter. As a result, manufacturers will have to conduct clinical trials to a much greater extent than before.

In addition, the requirements for clinical studies are clarified and increased (Article 62 and Annex XV). The MDR calls clinical studies "clinical investigation." For all Class III devices and Class IIb devices intended to administer a drug (or to be removed from the body), the manufacturer may consult an expert panel to obtain an advance review of its planned clinical development strategy.

For Class III and implantable devices, manufacturers must prepare a summary report on safety and clinical performance. The summary report should also be understandable to patients and be deposited in the Eudamed database. The summary report is part of the technical documentation.

What requirements does the MDR place on market monitoring?

Post-market surveillance (PMS) refers to the monitoring of a medical device after it has been placed on the market by the manufacturer. For this purpose, he actively and systematically collects information on product use in the market. In this way, the manufacturer determines whether corrective or preventive measures are necessary and, if so, informs the competent authorities (vigilance) or the Notified Body.

According to the MDR, manufacturers must set up a PMS process as part of their quality management system. This must be appropriate to the risk class and type of device and ensure that data on the quality, performance and safety of a device are actively collected and analyzed throughout the life of the device.

Post-Market Clinical Follow-Up (PMCF) refers to the clinical follow-up of a product after it has been placed on the market. It is an ongoing process that keeps the mandatory clinical evaluation of the product current. Post-Market Clinical Follow-Up is a component of Post-Market Surveillance.

Conclusion

The application of the MDR has been mandatory since May 26, 2021.

Manufacturers should check in particular in detail to what extent the partly complicated transitional provisions apply. During the transition period, directive- and regulation-certified products will coexist on the market.

Due to the many changes, steadily increasing number of guidances and other recommendations, the lack of Notified Bodies and the partly contradictory interpretation of the new rules, manufacturers will have to "drive by sight", which is unfortunately the opposite of what would benefit patients, staff and manufacturers in a highly regulated environment.

The practical feasibility of the MDR will be determined primarily through dialogue between manufacturers, Notified Bodies and relevant expert bodies, e.g. in standardization. Unfortunately, the MDR has significantly increased the scope of the rules, but not their precision and consistency.

Please refer to VDE Health for information on rule interpretations and current developments around the MDR. We will be happy to help you with all questions regarding approval and compliant implementation of all processes. If you need a dedicated process plan for your medical device, we recommend our "CE-Roadmap".

Companies now have to take high risks in order to be innovative. Regulatory requirements are hampering market success. The situation has worsened for small, medium-sized and young companies in particular. But for researchers in clinics, universities or research institutions, too, the documentation constraints make it considerably more difficult to connect their work and thus the likelihood of transfer. The DGBMT 'Regulatory Affairs' expert committee is therefore addressing the question of what improvements should be made to the MDR. Please get in touch if you are interested in participating.