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). 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, several other deadlines have changed. This article provides an overview of the major changes introduced by the MDR and the current status of implementation.
- What is the current status of the MDR implementation?
- What does the change to the MDR of April 23, 2020 include?
- What changes does Corrigendum II of the MDR contain?
- What are the main changes resulting from the MDR?
- How has the scope changed?
- Which definitions and obligations have changed in the MDR?
- What changes are there in the risk classification?
- What has changed for notified bodies?
- What is the Unique Device Identification (UDI)?
- What is new regarding the conformity assessment?
- What requirements does the MDR place on clinical evaluation?
- What requirements does the MDR place on market observation?
What is the current status of the MDR implementation?
The practical implementation of the MDR requirements by the manufacturers is currently running. The topic has long dominated the medical technology industry and, according to current surveys, is even rated more challenging than the effects of the Covid-19 pandemic.
In fact, the regulatory requirements are substantial and need interpretation. Several aspects such as the rules for risk classification, the practical implementation of clinical evaluations or the fulfillment of information security requirements are subject to intensive professional discussions.
The situation is made more difficult by the fact that several prerequisites have not yet been created, which are the basis for the MDR implementation. These are in particular:
- Notified bodies: Now only 18 organizations are notified according to MDR. In addition, not all notified bodies cover the entire specialist spectrum. As a result of Covid-19, many on-site audits are 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 implemented, which are intended to regulate individual provisions in more detail. Only 3 legal acts have been issued by the EU Commission so far, including 1 common specification.
- Harmonized standards: These help with the implementation of the general 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. Discussions between the European standardization organizations and the European Commission are going on.
- Guidelines: 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 constantly being published, explanations on many aspects are still missing. In addition, the practicability of the MDCG guidelines appears to need 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 many registration obligations being obligatory for manufacturer as well as for 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 effort.
- Expert committees: The MDR provides for the participation of expert committees in conformity assessment procedures for certain medical devices. These bodies do not yet exist.
The above aspects as well as the abundance of laws, rules and recommendations mean that relevant specialist groups wrestle with terminology, definitions and delimitations. In particular, smaller companies 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 various medical devices and companies will have to leave the market.
What does the change to the MDR of April 23, 2020 include?
The EU has decided that the date of application of the MDR is postponed by one year, i.e., to May 26, 2021 and justified this with the COVID-19 related challenges and the complexity of the MDR. The postponement of the date of application affects several provisions of the MDR. The following are specifically affected:
- adopting common specifications (Art. 1)
- handling of single-use products and their reprocessing (Art. 17)
- functionality of the EUDAMED data base (Art. 34)
- derogation from conformity assessment procedures (Art. 59)
- rules on penalties (Art. 113)
- transitional provisions (Art. 120-123)
Additional changes were introduced regarding conformity assessments and CE marking. 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 eliminate any bottlenecks of supply with vital medical devices. This case occurs, when a responsible national authority allows medical devices to be on the market without conformity assessment procedure. A prerequisite is a justification aimed at health protection or patient safety in the sense of a national exception regulation.
The period of validity for existing certificates and for certificates for higher-classified Class I products ends – as before – on May 26, 2024. The period for placing “old” medical devices on the market or putting them into service (“sale period”) ends unchanged on May 26, 2025. These periods have not been postponed a year. This has led to criticism, because the effect of the extension is partially canceled at this point.
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 the directives to regulations. Manufacturers of class I medical devices holding a valid directives certificate, who would have to classify their products higher according to the MDR, are now allowed to place these products on the market until May 26, 2024. This new rule can be used among others for reusable surgical instruments (Class Ir) and medical apps.
However, manufacturers are not allowed to make any major 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 must be met. Nevertheless, the 2nd Corrigendum of the MDR should be a considerable relief for the manufacturers.
What are the main changes resulting from the MDR?
Compared to the directives, the MDR contains additional requirements. No requirements have been deleted. In particular, the MDR
- has a wider scope and expressly includes all products for cleaning, sterilizing or disinfecting other medical devices, reprocessed disposable medical devices and certain products without a medical purpose,
- requires a safety and security approach that is oriented towards the entire product life cycle and is supported by clinical data,
- places higher demands on notified bodies,
- is introducing a consultation by an independent panel of experts in the clinical evaluation of certain high-risk products,
- introduces a system for the identification and tracking of medical devices,
- requires manufacturers to enter extensive data into the EUDAMED database and
- sets requirements for the sale of medical products via the Internet and 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 devices for removing fat.
Special rules apply to products that combine a medical device with an in vitro diagnostic device or a “medicinal product”, i. e. a drug (Article 1, paragraphs 7, 8 and 9). In the case of a combination with a drug, the manufacturer must differentiate to what extent device and drug belong together and what function the drug component has about 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 several 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
- have a risk management system (paragraph 2),
- have a quality management system (paragraph 9),
- carry out a clinical evaluation (paragraph 3),
- prepare a technical documentation (paragraph 4),
- and to apply a conformity assessment procedure (Paragraph 6).
Manufacturers are also responsible for their medical devices when they are on the market. To do this, they must, among other things, appoint a person responsible for regulatory compliance (Article 15). Manufacturers of an implantable product must provide an implant card with certain important information 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 put the CE conformity marking on their products (Article 20). Manufacturers who are not established in an EU member state designate an authorized representative. The MDR sets out the obligations of authorized representatives (Article 11), importers (Article 13) and distributors (Article 14) in detail.
What changes are there in the risk classification?
Manufacturers must classify their products in classes I*, IIa, IIb and III, considering their intended use and the associated risks. The risk classes are required for the further steps of the CE marking, for the choice of the conformity assessment procedure and for the scope of the clinical evaluation. Annex VIII contains 22 classification rules. These have tightened significantly. Manufacturers should particularly consider the following classification rules:
- rules 5-8: invasive products, surgically 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 has changed for notified bodies?
The requirements for notified bodies have increased significantly with the MDR (Chapter IV). They must meet significantly stricter criteria, especially about 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 fulfills the requirements has been commissioned to carry out the conformity assessment in accordance with the regulation.
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 professional suitability of a notified body, the need for data on products and the specification of the requirements from the MDR.
What is the 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 product 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 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 always keep all UDI-related data up to date.
What is new regarding the conformity assessment?
The conformity assessment route to be used 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, but with a limited procedure. These are:
- products that are placed on the market in a sterile state (Is),
- products with measuring function (Im) and
- reusable surgical instruments (Ir).
In addition, there is a new consultation process for clinical evaluation for certain Class IIb and III devices. For this purpose, an independent panel of experts should be involved based on the assessment report of the notified body (Article 54).
The MDR also specifies the general safety and performance requirements in Appendix I. 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 establish “Common Specifications”, which it can issue as implementing acts (Article 9). These can lead to additional requirements for manufacturers.
What requirements does the MDR place on 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, carry out clinical studies in order to demonstrate the safety and benefits of a product. However, manufacturers can now only use comparative data (“equivalence data”) in certain cases, as the new MDR rules are stricter. This means that manufacturers must 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 investigations”. 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 to obtain 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 type of product and ensure that data on the quality, performance and safety of a product are actively collected and analyzed over the entire 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 to what extent transitional provisions apply. During the transition period, medical devices being compliant to the directives and the MDR will coexist on the market.
Due to the Covid-19 pandemic, we must assume that there will be further changes to the plan. “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 primarily emerge from the dialogue between manufacturers, notified bodies and relevant specialist bodies, e.g., in standardization. Unfortunately, the MDR has increased the scope of the rules considerably, but not their precision and consistency.
Please refer to VDE Medical Devices and Software for information on standard interpretations and current developments relating to the MDR.