Last updates Jun 20, 2022
Several companies have notified members of AEPC that they will or have already withdrawn several medical devices from the European market that are frequently used in the treatment of congenital heart disease.
The reason for this withdrawal is apparently the huge cost associated by the European Medical Device Regulation (EU-MDR, 2017/745). This regulation aims to protect the European citizen and has little impact on devices from large companies with high volume well-priced devices. However, it has become apparent that in several niche markets consisting of highly specialized small volume low-to-medium cost devices (for example congenital heart disease interventions), the consequences for patients are likely to be enormous.
Without action we expect the treatment of newborns, babies and children with congenital heart disease to significantly regress in Europe by 2024 due to lack or shortage of such medical devices, despite their good performance over the last years/decades.
The AEPC Interventional Cardiology Working Group, backed by the AEPC council, has created a task force to improve the transition to EU-MDR, keeping efficacy and safety high on the priority list, but also the availability of established and new devices.
Below is the letter addressed to different organs of the European Community
It is also available here as a PDF, so you can share it with your national reprepsentative
For any questions, please address the AEPC EU-MDR taskforce through Marc Gewillig.
To WHOM it may concern
June 14 2022
The European Medical Device Regulation (EU-MDR, 2017/745) from 05.04.2017 was designed in order to improve the safety of medical products and follows the Medical Device Directive (MDD 93/42/EWG, 1983). This new EU-MDR became applicable from 26.05.2021 in all the European countries. The regulation has little impact on large companies with high volume well-priced devices. However, it has become apparent that in several niche markets consisting of highly specialized small volume low-to-medium cost devices (for example congenital heart disease interventions), the consequences for the patients and physicians are likely to be enormous. Although the intention of EU-MDR was commendable and idealistic, it will have significant impact on the availability of Medical Products (MP) within niche subspecialties, such as Pediatric Cardiology and Pediatric Heart Surgery.
All previously registered medical products (MP) will have to undergo a review process within 3 years (from 26.05.2021 to 26.05.2024) regardless of prior certification, in accordance with MDD, including technical review and reports on clinical data. This process is carried out by Notified Bodies (NB), which as private institutions, also have to be certified for this procedure. As they now have to organize certification of all medical products class I-III in accordance with EU-MDR by 2024, and there are approximately 25.000 MPs, the timeline for this process is too short and there are inadequate number of NBs dealing with the vast number of MPs. As each new MP also has to be certified by NB in accordance with the EU-MDR, this will additionally reduce the number of new or available MPs reaching Europe in our field, thus having a significant impact for our patients in foreseeable future.
The new EU-MDR was designed in order to increase the safety and the efficacy of MPs for all the patients. The field of Pediatric Cardiology is very small and highly specialized, compared with the adult specialties (overall < 1%), and the doctors have been using MPs in newborns, infants, babies, children and adults in order to perform life-saving treatments for decades. The treatment of Congenital Heart Disease, therefore, includes many MPs with a high specification (such as guidewires, catheters, stents, balloons, implants and devices), with most of them having been used clinically for many years. Due to the relatively low incidence of congenital heart disease, and the extremely high variability of the disease spread over different age and weight groups, there is a need for many MPs that may have wide applications. Moreover, due to the wide distribution of numbers over different pathologies and the range of sizes, many MPs may be used in only a few cases each year, and are typically used in “off label” application (estimation 20-30% of applications).
Today and with the expiration date for the EU-MDR of 26.05.2024 approaching, many devices used in congenital heart diseases have already been withdrawn or may not be available in the future. This will have a huge impact on the treatments we can offer for babies and children with congenital heart defects and raises a major concern in all the European physicians, who offer high quality treatments with extremely low mortality, as was highlighted recently during the Annual AEPC meeting in Geneva.
Already in 2022 and certainly by 2023, an increasing number of MPs will no longer available in Europe. This is because the companies manufacturing MPs for our specialty cannot have these certified in accordance with EU-MDR, as highlighted in points 1-7 above. This means that we will be unable to offer many life-saving treatments to babies and children with congenital heart defects and so there will be a huge impact on patient safety, with possibly more complications, increased mortality rates and costs. This needs to be brought to attention widely and steps taken to prevent this impact by MPs either disappearing from the market or not being available until re-certification is completed.
The goal of MDR is to protect the European citizen by improving the safety of medical products. This goal probably will be reached in high-volume MD. However in niche fields with low-volume MDs, MDR will result in either withdrawal of MD from the market, or availability at a much higher price. This will not be beneficial for the European patient with an orphan disease.
For this purpose, we have prepared a list of MP at risk for discontinuation in accordance to the EU-MDR within the community of Paediatric Cardiologists in Europe (see table 1). This list was prepared in cooperation with the MP companies and derives from information, as good as is currently available. The time-frame for recertification is currently not predictable by the NBs for many MPs, changes might occur during application or evaluation by NB. Overall re-certification seems to be extremely difficult and time consuming especially for class 3 products.
There is a need for an immediate response by the EU, especially for all Medical Products (MP) widely in the field of Pediatric Medicine and especially in Pediatric Cardiology. Diseases in this specialty are included within the list of the European research Network Heart Guard; EU-MDR creates a huge contrast between the need of care for these patients and the difficulties to provide it in a proper way. Doctors from all the European countries including UK and USA have already raised their concerns about the possible lack of availability of MPs in Europe currently and in the near future during the Annual Meeting of the Association for European Paediatric and Congenital Cardiology (AEPC) held in Geneva between 25.05.2022 and 28.05.2022. Some of the companies have already stopped the production or marketing in Europe of several “life-saving” MPs. Many other MPs are also at risk of being completely withdrawn from the European market within the next 12 months. This will have a huge impact on the treatment strategies and risks to babies and children with congenital heart defects, not only in Europe, but also surrounding countries in Africa and Asia.
Therefore, the EU-MDR application needs to be modified and adapted to prevent children with congenital heart defects being denied treatments, which have a very positive track record over the last three decades.
The AEPC has created a task force for EU-MDR, which is available for further discussions and negotiations with the representatives of EU-MDR in the EU.
Please do not hesitate to contact us, if you need further clarification or any other information.
Prof. Dr. Nico Blom, AEPC President, The Netherlands
Prof. Dr. Katarina Hanséus, AEPC past President, Sweden
Prof. Dr. Marc Gewillig, Belgium
Prof. Dr. Stephan Schubert, Germany
Dr. Petru Liuba, Sweden
Prof. Dr. Gianfranco Butera, Italy
Prof. Dr. Sigitas Cesna, Lithuania
Prof. Dr. Pedro Betrian, Spain
Prof. Dr. Alban-Elouen Baruteau, France
Prof. Dr. Regina Bokenkamp, Chairman AEPC Interventional Cardiology working group, The Netherlands
Prof. Dr. Thomas Krasemann, Secretary AEPC Interventional Cardiology working group, The Netherlands
Prof. Dr. Massimo Chessa, Treasurer AEPC Interventional Cardiology working group, Italy
Prof. Dr. Osman Baspinar, Turkey
Prof. Dr. Andreas Eicken, Germany
Dr. Nicholas Hayes, United Kingdom
Dr. Robin Bertels, The Netherlands
Prof. Sonia El Saiedi, Egypt
Dr. Queennette Daniels, The Netherlands
Sir Prof. Shakeel Qureshi, United Kingdom
Dr. Bruno Lefort, France
Prof. Dr. Nikolaus A. Haas, Past President of the German Society for Pediatric Cardiology and Congenital Heart Defects (DGPK), Germany
Prof. Dr. Jose Luis Zunzunegui, Spain
Prof. Dr. med. Matthias Gorenflo, Germany