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The EU Medical Device Regulation (MDR): What is changing?
The European Medical Device Regulation (EU) 2017/745 (MDR) replaces the Medical Device Directive (93/42 / EEC, MDD) and the Directive on active implantable medical devices (90/385 / EEC, AIMDD).
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The MDR was published on May 25, 2017. The transition period originally lasted 3 years. In view of the COVID-19 pandemic, the EU Commission has extended this transition period to May 25, 2021. As a result, a number of other deadlines have changed. This technical article provides an overview of the main changes brought about by the MDR and the current status of implementation.
What is the current status of the MDR implementation?
The practical implementation of the MDR requirements by the manufacturers is in full swing. The topic has long dominated the medical technology industry and, according to current surveys, is even rated as even more challenging than the effects of the Covid 19 pandemic.
What is certain is that the regulatory requirements are substantial and in need of interpretation. A number of aspects such as For example, the rules for risk classification, the practical implementation of clinical assessments or the fulfillment of information security requirements are subject to regular professional discussions.
The situation is made more difficult by the fact that a number of prerequisites have not yet been created, which are the basis for the MDR implementation. These are in particular:
- Notified bodies: At the moment only 17 organizations are named according to the MDR. In addition, not all notified bodies cover the entire technical spectrum. As a result of Covid-19, many on-site audits are also not possible, so that a further bottleneck can be assumed, especially for initial certifications.
- Legal acts: The MDR refers to around 50 legal acts still to be enacted, which are intended to regulate individual provisions in more detail. At this point in time, only 3 legal acts have been issued by the EU Commission, including a common specification.
- Harmonized standards: These help with the implementation of the basic safety and performance requirements of the MDR and, when used accordingly, trigger a presumption of conformity. However, these standards do not yet exist. It is currently unclear whether and, if so, when harmonization will be carried out by the EU Commission.
- Guides: The EU Commission has set up the European Coordination Group for Medical Devices (MDCG) with the aim of explaining and interpreting the MDR in view of the difficulties of interpretation. Even if new MDCG guidelines are published all the time, explanations on a large number of aspects are still missing. In addition, the practicability of the MDCG guidelines appears to be in need of improvement in some cases and the number of documents to be read and understood is steadily increasing.
- EUDAMED: The European medical device database EUDAMED is the basis for a large number of registration obligations both on the part of the manufacturer and on the part of the notified bodies and authorities. The database is currently not fully operational. Due to the central role of the database, this leads to considerable delays and, in some cases, additional work.
- Expert bodies: The MDR provides for the participation of expert committees in conformity assessment procedures for certain medical devices. At this point in time, these bodies do not yet exist.
The above Aspects as well as the sheer abundance of laws, rules and recommendations mean that relevant specialist groups struggle to interpret terms, definitions and delimitations. Smaller companies in particular will 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 have to leave the market.
What does the change to the MDR of April 23, 2020 include?
On April 3, 2020, the EU Commission published a proposal to change the MDR. In it, the EU Commission proposed to postpone the start of application of the MDR by one year, i.e. to May 26, 2021. She justified this proposal with the challenges caused by COVID-19 and the complexity of the MDR. It therefore assumed that the actors involved would not be able to implement the regulation on May 26, 2020 - the previous date of application.
The postponement of the start of application as proposed by the Commission came into force on April 24, 2020 and affects a number of provisions of the MDR. The following are specifically affected:
- Issuing common specifications (Art. 1)
- Handling of single-use products and their reprocessing (Art. 17)
- Functionality of the EUDAMED database (Art. 34)
- Exception to conformity assessment procedures (Art. 59)
- Rules on sanctions and violations (Art. 113)
- Transitional provisions (Art. 120)
- Repeal of directives 90/385 / EEC and 93/42 / EEC (Art. 122)
- Entry into force and beginning of application of the MDR (Art. 123)
On the one hand, the change to the transitional provisions according to Art. 120 should be emphasized. This led to the question of how affected products should be treated between May 26, 2020 and 2021. It did not seem plausible that the EU Commission would weaken a relief introduced in December 2019 in view of the increasingly tightening framework conditions. In the course of the legislative process between the Commission, Council and Parliament, these adjustments were made.
On the other hand, changes in the handling of conformity assessments and the associated CE marking have been introduced. Both the (AI) MDD and the MDR already allow the responsible national authorities to bring medical devices onto the market without a conformity assessment procedure. A prerequisite is a justification aimed at health protection or patient safety in the sense of a national exception regulation.
With the MDR amendment, in view of the COVID-19 crisis, the EU Commission has ensured that it can react “immediately” with Union-wide exemptions based on special approvals according to Art. 59 MDR and resolve any bottlenecks in essential medical devices.
The period of validity for old certificates and for certificates for higher-classified Class I products ends as before on May 26, 2024. The period for commissioning or provision for old products (“sale period”) ends unchanged on May 26, 2025. These periods have not been passed postponed a year.
What changes does Corrigendum II of the MDR contain?
The 2nd Corrigendum to the MDR changes in particular Article 120 (3), which defines the transitional provisions from (AI) MDD to MDR. Manufacturers of class I medical devices with a valid (AI) MDD certificate, who have to classify their products higher according to the MDR, are now allowed to market these products until May 26, 2024. Reusable surgically invasive products of the (Ir class) and medical apps can benefit from this new rule.
However, manufacturers are not allowed to make any significant changes to their medical devices within the extended period that could affect conformity. In addition, the requirements of the MDR for post-market surveillance, market surveillance, vigilance and registration obligations must be met. The 2nd Corrigendum of the MDR should nevertheless lead to a noticeable facilitation of the conversion from guidelines to prescriptions for manufacturers of the above-mentioned medical devices.
What are the main innovations in the MDR?
Compared to the (AI) MDD, the MDR contains additional requirements. No requirements have been deleted. The main innovations are as follows:
- The MDR has a broader scope and expressly includes all products for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices and certain products without a medical purpose.
- The MDR calls for a safety approach that is based on the entire product life cycle and is supported by clinical data.
- The MDR places higher demands on notified bodies.
- The MDR introduces consultation by an independent panel of experts in the clinical evaluation of certain high-risk products.
- The MDR introduces a system for the identification and tracing of products.
- The MDR requires manufacturers to enter extensive data in the EUDAMED database.
- The MDR sets requirements for the sale of medical products over the Internet and for their distance selling.
How has the scope changed?
The scope of the MDR has expanded (Article 1). Manufacturers must review their product portfolio to determine whether other products fall within the scope of the MDR.
Article 1 also lists in paragraph 6 those products that do not fall within the scope of the MDR. This applies, for example, to in vitro diagnostics. These are regulated by a separate EU regulation (2017/746, IVDR). Another prominent example is pharmaceuticals.
In addition, Annex XVI contains a list of products whose intended use is not medical, but which still fall within the scope of the MDR. Examples are contact lenses or grease removal devices.
Special rules apply to products that combine a medical device with an in-vitro diagnostic device or a medicinal product (Article 1, paragraphs 7, 8 and 9). In the case of a combination with a drug, the manufacturer must in particular differentiate the extent to which the device and drug belong together and what function the drug component has with regard to the overall effect. According to this, the regulatory classification is based either on 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).
Which definitions and obligations have changed in the MDR?
Overall, the MDR contains a number of changed and new definitions of terms. Important examples in Article 2 are:
- the definition of a medical device (paragraph 1),
- the unique device identifier (UDI) (paragraph 15),
- clinical data (paragraph 48),
- clinical evidence (paragraph 51) and
- serious incident (paragraph 65).
Article 10 of the MDR obliges manufacturers to
Manufacturers are also responsible for their medical devices as soon as they are on the market. To do this, they must, among other things, designate a “responsible person” who is responsible for compliance with the regulations (Article 15). Manufacturers of an implantable product must present an implant ID card for the patient (Article 18).
As soon as they have fulfilled all these obligations, the manufacturers draw up an EU declaration of conformity (Article 19) and bear the CE conformity marking on their products (Article 20). Manufacturers who are not established in an EU member state commission an authorized representative. The MDR sets out the obligations of authorized representatives (Article 11), importers (Article 13) and dealers (Article 14) in detail.
What changes are there in the risk classification?
Manufacturers must classify their products in classes I, IIa, IIb and III, taking into account their intended use and the associated risks. The risk classes are required for the further steps of the CE marking, in particular for the choice of the conformity assessment procedure and for the scope of the clinical assessment. Annex VIII contains 22 classification rules. These have tightened significantly. Manufacturers should particularly consider the following classification rules:
- Rules 5 - 8: Invasive Products, Surgical Invasive Products, and Implantable Products
- Rules 9-13: active products
- Rule 11: software (is an active product)
- Rule 18: Products Using Tissues and Cells
- Rule 19: Products containing nanomaterials and
- Rule 21: Products Made of Substances.
What will change with Notified Bodies?
The requirements for notified bodies have increased considerably with the MDR (Chapter IV). They have to meet significantly stricter criteria, especially with regard to the presence of clinical competence.
Suitable organizations must apply for a designation from the relevant competent authority. Auditors from various national and European authorities are involved in the designation process. Notification is a legal act in which a Member State informs the Commission and the other Member States that an organization that meets the requirements has been entrusted with carrying out the conformity assessment in accordance with the Directive.
Manufacturers must check which notified body is suitable 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 relate to the availability and technical suitability of a notified body, the need for data on products and the specification of the requirements from the MDR.
What is Unique Device Identification (UDI)?
The MDR introduces a system for unambiguous product labeling (UDI). The aim is to improve the identification (Article 27) and traceability (Article 25) of medical devices. Accordingly, every medical device must have a UDI. This consists of 2 parts:
- a product-specific identifier (UDI-DI) to identify the product and manufacturer as well as
- a production identifier (UDI-PI) to identify the production unit.
The manufacturers are responsible for entering all UDI-related data into the European medical device database EUDAMED. This includes the UDI database. Manufacturers must keep all UDI-related data up to date at all times.
What innovations are there in the conformity assessment?
The conformity assessment procedure of a product depends on the risk class and specific product properties (Article 52, Annexes IX, X and XI). The manufacturer must consult a notified body for products of classes IIa, IIb and III. There are also some Class I devices, albeit with a limited procedure. These are:
- Products that are placed on the market in a sterile state,
- Products 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 should be involved on the basis of the assessment report of the notified body (Article 54).
The MDR also specifies the general safety and performance requirements in Annex I in detail. The same applies to the structure of the technical documentation in Annexes II and III. Manufacturers must begin the clinical evaluation with a clinical evaluation plan (Annex XIV). In addition, the EU Commission reserves the right to “Common Specifications”, which it can issue as implementing acts (Article 9). These can lead to additional requirements for manufacturers.
What are the requirements of the MDR for clinical evaluation?
The MDR significantly tightened the requirements for clinical evaluation (Article 61). As before, a manufacturer must analyze and evaluate clinical literature data and, if necessary, carry out clinical studies in order to prove the safety and benefits of a product. However, manufacturers can now only fall back on comparative data ("equivalence data") in certain cases, as the new MDR rules are stricter. As a result, manufacturers have to conduct clinical studies on a much larger scale than before.
In addition, the requirements for clinical studies are specified and increased (Article 62 and Annex XV). The MDR calls clinical studies "clinical trials". For all Class III and Class IIb devices that are intended to be used to administer a drug (or to be withdrawn from the body), the manufacturer can consult a panel of experts for an early review of its planned clinical development strategy.
For Class III and implantable devices, manufacturers are required to provide a brief safety and clinical performance report. The short report should also be understandable for patients and should be stored in the EUDAMED database. The short report is part of the technical documentation.
What requirements does the MDR place on market observation?
Post-Market Surveillance (PMS) refers to the monitoring of a medical device by the manufacturer after it has been placed on the market. To do this, he actively and systematically collects information on product use in the market. In this way, the manufacturer determines whether corrective or preventive measures are required and, if necessary, informs the competent authorities 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 the type of product and ensure that data on the quality, performance and safety of a product are actively collected and analyzed throughout the product lifecycle.
The Post-Market Clinical Follow-Up (PMCF) describes 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 up to date. The post-market clinical follow-up is part of the post-market surveillance.
The transition period ends on May 25, 2021.
Manufacturers should check in particular to what extent transitional provisions apply. During the transition period, (AI) MDD and MDR certified products will coexist on the market.
Due to the COVID-19 pandemic, we have to assume that there will be further plan changes in large numbers. “Driving on sight” is currently the trend, which is unfortunately the opposite of what patients, staff and manufacturers would benefit from in a highly regulated environment.
The practical feasibility of the MDR will mainly be reflected in the dialogue between manufacturers, notified bodies and relevant specialist committees, e.g. B. in standardization. Unfortunately, the scope of the rules has increased significantly as a result of the MDR, but not their precision and consistency. Please refer to VDE MeSo for information on standard interpretations and current developments relating to the MDR.
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