Information on the European Medical Device Regulation
In May 2020, the transition period for the new European Medical Device Regulation will end with many new rules and challenges for all involved.
B. Braun is also preparing intensely. Here we have compiled some information about the MDR for you.
The new European Medical Device Regulation (MDR) went into force in May 2017. The new regulation replaces the existing Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). Until the stipulated transition period ends in May 2020, medical devices may continue to be certified according to the current directives. For the ln-vitro-Diagnostic Regulation (IVDR), which replaces the ln-vitro-Diagnostic Directive (IVDD), there is a different transition period of 5 years until May 2022, with an additional 2 years under certain conditions.
In the future, the current approx. 500,000 medical devices in Europe will be recertified in accordance with the new, substantially more comprehensive policy to receive the CE mark. According to current estimates, approximately only 65 percent of the medical devices will be certified according to the new regulation. Currently, the majority of notified bodies are still in their accreditation phase. It is still unclear as to how many notified bodies will be able to conclude the process and at which point in time. Due to the increased requirements placed on the notified bodies and the manufacturers, portfolio adjustments are expected and are inevitable.
Which regulatory areas are affected?
Among others, these areas are affected:
- The rules have been extended to include Class Ir (reusable surgically invasive instruments).
- The requirements related to implantable products of Class llb have increased.
- New risk classes have been introduced for several product categories, which potentially entails products being up-classified.
- In the future, all medical devices are subject to a clinical evaluation obligation regardless of the class.
- New implantable Class III devices and Class llb active devices which administer and /or remove medicinals are to be more strictly controlled before market entry.
- The requirements placed on the notified bodies are increasing. At the same time, they will in the future be obliged to perform unannounced audits at manufacturers.
- Documentation due to the MDR increases significantly the effort for manufacturers.
- An electronic database for monitoring the product lifecycle has been introduced.
What kinds of challenges exist?
In order to be able to ensure continuous supply with safe and innovative medical technology, all manufacturers are faced with the challenging task of overcoming the increased requirements necessary to receive the CE mark. The notified bodies must lay the foundation and create sufficient capacity for the conformity assessment procedure. Currently it is unclear whether this can be realistically accomplished within the well-known given timeframe for the implementation of the MDR.
At an earlier point in time, B. Braun already began wide-ranging preparations for the certification of its own medical devices in accordance with the MDR. Naturally, this applies to all products that B. Braun manufactures itself or purchases as commercial goods to complete its portfolio. With regard to the progress of the measures taken, B. Braun is confident it will be able to comply with the requirements of the MDR.
General FAQs concerning the MDR
What are the reasons behind the Medical Device Regulation?
A revision of the Medical Device Directive 93/42 EEC (MDD), which was made public in 1993 and still applies today, became necessary at the European level. With the new regulation, EU authorities would like to improve the quality of medical devices and enhance safety, harmonize the processes through the EU, and increase patient safety. Additional aspects include the improvement of transparency and traceability in connection with new technologies that allow for the clear identification of all products throughout their entire lifecycle.
What is regulated in the Medical Device Regulation (MDR)?
The MDR defines the requirements that a manufacturer must meet in order to sell medical devices in Europe. Both the technical requirements for a product and the requirements placed on the monitoring of products used in healthcare facilities are affected. In contrast to the previous directive, the MDD, the MDR is a European regulation that also applies in Germany and that doesn’t have to be implemented in accordance with German law, for example. Currently, a transition period is in effect until May 2020, by which product information, together with unique device identifier (UDI) data, must be transmitted to the European Database on Medical Devices (EUDAMED).
What kinds of significant changes will result from the Medical Device Regulation (MDR)?
There are several changes surrounding the classification of products. In addition to the introduction of the new Class lr for reusable surgical instruments, the requirements placed on implantable products of Class IIb have been especially increased. Furthermore, numerous product categories have been assigned to a higher risk class. The MDR increases the requirements pertaining to the clinical evidence of medical devices. In the future, all medical devices, regardless of their risk class, will require a clinical evaluation. The newly introduced scrutiny procedure means the improved monitoring of new, implantable products of Risk Class III, as well as active medical devices which administer dand/or remove medicinals of Class IIb before market launch. In addition to the increased requirements placed on manufacturers, there are now stricter rules imposed on notified bodies. In order to be able to approve medical devices, various additional requirements must be met. Also, the notified bodies are obliged to perform unannounced audits at manufacturers. Additional requirements placed on the technical documentation that must be provided by manufacturers is substantially increasing the extent and complexity of the documentation.
What is EUDAMED?
Data that is relevant for the public is made accessible in a central European database that already exists today. The expanded version of EUDAMED will be introduced by mid 2020. Legal manufacturers, importers, or authorized representatives for the distribution of medical devices in the EU must add to EUDAMED data pertaining to the role of the actor, as well as the product-relevant data for each individual product to be distributed in the EU.
Does the MDR affect all products?
Yes, all medical devices of all risk classes, including the treatment units and systems, are affected. Comparable impacts also affect In-vitro diagnostics, the placing of which on the market is regulated in the new ln-vitro-Diagnostic Device Regulation (IVDR).
What is the timetable of the MDR introduction?
After the MDR was published on May 5th, 2017, the regulation went into force on May 25th, 2017, with a transition period that extends to May 26th, 2020. Until max. May 26th, 2024, MDD certificates will maintain their vadility (e.g. for products of risk classes II and III), unless it is required that an MDD certificate is to be replaced by an MDR certificate (e.g. for products of risk class 1). After May 26th, 2025, products with an MDD certificate may no longer be placed on the market.
What is the conformity assessment?
The conformity assessment says whether a product and the respective manufacturer complies with the European MDR requirements. Depending on the risk classification of the individual products, B. Braun is entitled to carry out this audit itself. The additional evaluations are carried out via a so-called “notified body”. As before, there are three risk classes, with the new risk class lr being introduced for reusable surgical instruments. Aesculap AG, as an established manufacturer and supplier of surgical instruments, is especially preparing itself intensively for the new requirements.
What is a notified body?
A notified body is a private company that is named on behalf of the European Union to evaluate the conformity of a manufacturer with the MDR. The notified bodies for B. Braun Melsungen AG are TÜV SÜD, MedCert, Dekra, and others. Currently they are being evaluated with audits and after they have passed the audits, the notified bodies will then evaluate the processes of medical device manufacturers for MDR conformity. As soon as the compliance of the processes has been verified, products that are processed can be registered through these processes.
FAQs concerning the MDR & B. Braun
To what extent is B. Braun affected by the MDR?
As a manufacturer of medical devices, B. Braun must comply with the requirements by May 2020. Different work groups are updating the technical documentation and revising processes in order to ensure they are MDR compliant. Furthermore, B. Braun is obliged to provide product information, including unique device identification data (UDI), as well as post market surveillance information to EUDAMED.
Which B. Braun products are affected?
All medical devices and ln-vitro diagnostics. Also, all products that are certified for the first time in accordance with the new Class Ir.
Do reusable products of Class I without certification have to be recalled?
No, all products that were placed on the market before May 25th, 2020 can be distributed for an additional five years.
Will B. Braun be able to adhere to the set timeline?
For some time, B. Braun has been preparing itself intensively for the new regulations and assumes it will be able to adhere to the timeline.
Will all B. Braun medical devices be certified according to the MDR?
Generally speaking, yes – depending on the planned lifecycle of a product, however, an extension of the certification according to MDD/AIMDD (distribution possible until 2025) can be taken into consideration.
Do the notified bodies responsible for B. Braun fulfill the future requirements?
TÜV Süd was recognized as the second notified body worldwide in May 2019.
What kinds of changes will the MDR bring about for B. Braun customers?
a) The identification of a medical device will change through the inclusion of the unique device identification (UDI).
b) It is possible that extended documentation obligations arise through new Class III products.
c) The EUDAMED database provides customers more transparency with regard to products.
What identifier will MDR-certified products receive?
With the introduction of the MDR, there will be a new symbol “MD” for medical devices that will be placed on the label.