Information on the European Medical Device Regulation
In May 2020, the transition period was intended to end for the new European Medical Device Regulation with many new rules and challenges for all involved. Due to the COVID-19 pandemic the mandatory application of the MDR was postponed by one year.
B. Braun is preparing intensely and wants to apply the new requirements as soon as possible. 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 2021, 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 (list on European Commission website). 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. Due to the COVID-19 pandemic, the transition period for mandatory application of the MDR was extended until May 2021.
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 and/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 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.
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 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 2022. 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.
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 was intended to last until May 26th, 2020. Due to the COVID-19 pandemic the mandatory application of the MDR was postponed to May 2021. Until max. May 26th, 2024, MDD certificates will maintain their validity (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.
Which MDR classes are operative at what date?
Due to the COVID-19 pandemic, the mandatory application for MDR was set for May 26th, 2021. This results in the following deadlines for the marketing of medical devices according to product classes:
Class I: May 26th, 2021
Class Ir, s, m, Class IIa, Class IIb and Class III: May 26th, 2024
Do reusable products of Class I without certification have to be recalled?
No, all products that were placed on the market before May 25th, 2021 can be distributed for an additional four years.
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”.
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. 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.
Which additional efforts remain after the transition period ends on May 26th, 2024?
Even after converting the entire product portfolio to MDR, manufacturers will face significant additional costs due to the increased requirements of the MDR.
Which added value does the MDR provide for manufacturers, healthcare providers and patients?
The main objectives of the regulation are better protection of public health and patient safety, more transparency, legal security and a more European-oriented concept. This is to be achieved through more extensive technical documentation on the affected products in an MDR-compliant quality management system.
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 2021. 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.
How is B. Braun implementing the MDR requirements?
The B. Braun Group has already initiated comprehensive measures and provided resources to ensure the on-schedule implementation of the MDR.
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.
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.
Has B. Braun already implemented the MDR requirements within the its quality management system or when is it planned to be completed?
The Hospital Care and OPM divisions of B. Braun Melsungen AG were already audited by the notified body TÜV Süd in accordance with MDR in September 2019 and the certificate was issued in March 2020. Aesculap AG and B. Braun Avitum AG also successfully passed the audit. We expect the certificates to be issued in a timely manner.
Will all B. Braun medical devices be certified according to the MDR?
Generally speaking, yes – depending on the planned lifecycle, the products are certified according to MDR. B. Braun is using the MDR transition period in which we will transfer our product portfolio to MDR by May 2024 at the latest. During this transition period, B. Braun will place both MDD and MDR certified products on the market.
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. Further notified bodies supervising medical devices of B. Braun are MedCert, Dekra and TÜV Rheinland which received their designation under MDR as well. Please check the link to the European Commission’s website to obtain an overview on MDR accredited notified bodies.
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 are the costs of the MDR at B. Braun?
B. Braun is MDR-ready and has already made high investments in the multi-digit million range to achieve this. Major cost factors are more comprehensive requirements for the technical documentation, technical and systemic solutions to meet the required EUDAMED data management as well as increased post market surveillance efforts.
Factsheet for healthcare professionals and health institutions European Commission Website
Medical Device Regulation Official Journal of the European Union
List of Notified bodies accredited under Regulation (EU) 2017/745 on medical devices European Commission Website