scholarly journals Development and manufacturing of a custom made implant regarding the new European Medical Device Regulation

2019 ◽  
Vol 5 (1) ◽  
pp. 253-256
Author(s):  
Mareike Schonhoff ◽  
Astrid Heinze ◽  
Juliette Carrillo ◽  
Annika Lopinski ◽  
Damian Großkreutz ◽  
...  
Keyword(s):  
Medical Device ◽  
Electron Beam Melting ◽  
New Technologies ◽  
Pelvic Bone ◽  
The European Union ◽  
Bone Contact ◽  
Reconstruction Process ◽  
Custom Made ◽  
Modular Implant ◽  
Medical Device Regulation

AbstractNew technologies are great opportunities for personalized medicine. Custom made implants can be very helpful for patients with severe bone defects or in case of bone tumor. Through the European Union it is regulated how many possibilities and restrictions all medical devices have. Because of critical vulnerabilities a new European Medical Device Regulation (MDR) was published in May 2017 and it will enter into force in May 2020. For the manufacturers of customized products it will change the documentation of the manufacturing and tracking of serious incidents. Patients with a pelvis defect of Paprosky IIb and higher can benefit from a custom made pelvis implant, because all planning steps according to biomechanic and bone contact to the implant can be designed and proofed during a reconstruction process. With regular modular implant systems, it probably can be a trial and error procedure during the surgery according to biomechanic and a stable position of the implant. Based on the 3D-Reconstruction of CT-Scans of a patient with a Paprosky 2b pelvis defect, a personalized acetabulum implant was designed. To maintain as much bone as possible, the implant was shaped to the remaining pelvic bone stock. Additive manufacturing gives the opportunity to produce custom made single items even in a quality that ful-fills the requirements of the MDR. Modern Selective Laser Melting (SLM) and Electron Beam melting (EBM) Systems are able to produce Titanium or CoCr parts in the ISO standards for Implants (ISO 5832 ff). In this study the process chain, starting from the reconstruction, to the design and the production of a custom made acetabulum cup was run through on an exemplary CTData of one patient. With this example, it was shown that it is possible, to establish a process, that is able to address surgical needs for patients that benefit from those techniques.

Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices

2021 ◽  
Vol 10 (1) ◽  
pp. 64-88
Author(s):  
James I. J. Green
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Transition Period ◽  
Eu Directive ◽  
Custom Made ◽  
Dental Setting ◽  
The Uk ◽  
Dental Professionals ◽  
The Eu ◽  
Medical Device Regulation

A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the coronavirus disease 2019 (COVID-19) pandemic. In the UK, in preparation for the country’s planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.

The Medical Device Regulation of the European Union Intensifies Focus on Clinical Benefits of Devices

2019 ◽  
pp. 216847901987073 ◽  
Author(s):  
Beata Wilkinson ◽  
Robert van Boxtel
Keyword(s):  
European Union ◽  
Medical Device ◽  
Clinical Evaluation ◽  
Medical Devices ◽  
Real World ◽  
The European Union ◽  
Clinical Investigations ◽  
Clinical Benefits ◽  
The Eu ◽  
Medical Device Regulation

This article comments on the new approach to the clinical evaluation of medical devices in the European Union (EU), which adds consideration of intended clinical benefits to the traditional focus on safety and performance. The article also discusses types of clinical benefits that may be claimed and how evidence for them may be generated. In the EU, determining the benefit-risk profile is an existing core requirement of the clinical evaluation performed according to MEDDEV 2.7/1 Rev 4 guidelines, but under the new Medical Device Regulation (MDR), “intended” clinical benefits must be determined first. The MDR sets high standards for ensuring reliable data are generated from clinical investigations. It stipulates that the endpoints of clinical investigations should include clinical benefits. However, many clinical-use questions arise only after a device is made widely available to patients. For all medical devices, particularly for on-the-market devices never subjected to randomized controlled trials and for new devices developed when these trials were inappropriate/impossible, the postmarket phase of the device is a valuable source of clinical-benefit data. Postmarket clinical follow-up can corroborate and refine predictions of clinical benefits over time. Indirect clinical effects, which may affect treatment adherence and influence patients’ well-being, may surface in the postmarket phase. Real-world clinical data will improve the manufacturer’s understanding of their device’s clinical benefits, potentially changing claims of intended clinical benefits in subsequent clinical evaluations. A paradigm change in clinical evaluation of medical devices in the EU will ensue when manufacturers ensure that their devices deliver real-world clinical benefits.

Medical Device Regulation: Implications for dental nurses

2021 ◽  
Vol 17 (1) ◽  
pp. 44-45
Author(s):  
James I J Green
Keyword(s):  
Medical Device ◽  
James I ◽  
Custom Made ◽  
Legislative Changes ◽  
Medical Device Regulation

James I J Green explores the legislative changes that will be affecting custom-made devices and what this means for dental nurses

scholarly journals Medical Device Regulation and current challenges for the implementation of new technologies

2020 ◽  
Vol 6 (3) ◽  
pp. 334-337
Author(s):  
Sebastian Kaule ◽  
Andrea Bock ◽  
Ariane Dierke ◽  
Stefan Siewert ◽  
Klaus-Peter Schmitz ◽  
...  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
New Technologies ◽  
Transition Period ◽  
Transitional Period ◽  
Technical Documentation ◽  
Transcatheter Aortic Valve ◽  
Innovative Products ◽  
One Year ◽  
Medical Device Regulation

AbstractThe European Parliament and the European Council on May 26, 2017 decided to introduce the new regulatory framework for medical devices. The transitional period of the so called Medical Device Regulation (EU 2017/745, MDR) should end on May 26, 2020. Currently the European Commission is working on a proposal to postpone the application for one year to relieve pressure from all stakeholders allowing them to fully focus on priorities related to the coronavirus crisis. From this date or most likely from May 26, 2021, manufacturers must present a CE-certificate according to the new MDR requirements not only for novel medical devices, but also for approved medical devices which are already on the market. The MDR will significantly complicate the process of bringing medical devices into market due to the increased requirements for the CE-certification process, particularly concerning increased documentation effort. This involves a risk for the translation of innovative products due to an overload of the overall system (manufacturers, Notified Bodies, experts) and might lead to shrinkage of the product range of existing products. Thankfully, adaption of transitional periods, special regulations, extensions of deadlines and most probably postponement of the MDR application date will ensure that there will be no gaps in medical supply that endanger patients. Establishing and keeping the relevant regulatory expertise up to date and devoting the necessary financial, time and human resources that is the biggest immediate challenge the medium-sized medical technology sector is facing in the near future. The current article, written about one month before the initially expected end of the first transition period on May 26, 2020, summarized the main aspects of the current state of MDR implementation with respect to regulatory novelties, the current legal basis in Germany, transition periods and changes in the requirements of CE-certification relevant technical documentation. Furthermore, challenges for existing and innovative medical devices were shortly discussed using a new stent based therapy of the proximal Fallopian tubal stenosis and transcatheter aortic valve implantation as two examples.

The impact of medical device regulation on hospital doctors who prescribe and manufacture custom-made devices

2020 ◽  
Vol 81 (12) ◽  
pp. 1-6
Author(s):  
James IJ Green
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
European Directives ◽  
Custom Made ◽  
Hospital Doctors ◽  
Safety Effectiveness ◽  
The Impact ◽  
Medical Device Regulation

The 1990s saw the implementation of three European directives that aimed to standardise medical device legislation. EU regulations replace and repeal these directives, to improve the safety, effectiveness and traceability of medical devices. This article discusses the implications of the Regulation (EU) 2017/745 (Medical Device Regulation) for hospital doctors who prescribe and manufacture custom-made medical devices.

Europäischer Medizinproduktemarkt: Wie sich Einkauf und Logistik auf die europäische MDR vorbereiten müssen

2019 ◽  
Vol 01 (04) ◽  
pp. 74-77
Author(s):  
Thomas Gallmann
Keyword(s):  
Medical Device ◽  
Medical Device Regulation

Nicht lieferbare Medizinprodukte sind für Kliniken ein Albtraum – mitunter müssen sogar geplante OPs abgesagt werden. Die Folge: Die mit den Kostenträgern vereinbarten Leistungszahlen sind schwieriger zu erfüllen und es könnte zu schwer kompensierbaren Erlöseinbußen für die Leistungserbringer kommen. Die Medical Device Regulation (MDR) wird die Liefersituation von Medizinprodukten ab 2020 wahrscheinlich noch weiter verschärfen.

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