scholarly journals 3D Bioprinting Regulations: a UK/EU Perspective

2017 ◽  
Vol 8 (2) ◽  
pp. 441-447 ◽  
Author(s):  
Phoebe LI ◽  
Alex FAULKNER
Keyword(s):  
Tissue Engineering ◽  
Regenerative Medicine ◽  
Medical Device ◽  
3D Bioprinting ◽  
Medicinal Products ◽  
Legal Regime ◽  
Advanced Therapy ◽  
Regulatory Instruments ◽  
The Eu ◽  
Medical Device Regulation

AbstractThis report introduces the challenges 3D bioprinting poses to the existing legal regime across bioethics, safety, regenerative medicine, and tissue engineering. We briefly review the 3D bioprinting technology and look into the relevant regulatory instruments for the pre-printing, printing, and post-printing stages. Special attention is paid to the applications of the EU Advanced Therapy Medicinal Products Regulation and the new Medical Device Regulation.

Exploratory assessment of the current EU regulatory framework for development of advanced therapies

1969 ◽  
Vol 16 (4) ◽  
Author(s):  
Pawanbir Singh ◽  
Laure Brévignon-Dodin ◽  
Satya P Dash
Keyword(s):  
Regenerative Medicine ◽  
Research And Development ◽  
Regulatory Framework ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Regulatory Strategy ◽  
Technology Changes ◽  
Advanced Therapy ◽  
Advanced Therapies ◽  
The Eu

The Advanced Therapy Medicinal Products (ATMP) Regulation provides a necessary regulatory framework for the commercialisation and use of regenerative medicine-based therapeutic products in the EU. However, concerns have been raised about the appropriateness of the regulatory strategy it has adopted to address different, complex and evolving categories of medicinal products. This article explores some of the potential shortfalls of the ATMP Regulation with regard to facilitating the research and development of advanced therapies in the present and in the future. It concludes that while providing a much needed harmonised regulatory framework for the companies operating in the sector, the new regulation has yet to demonstrate its capacity to keep up with radical technology changes.

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.

scholarly journals Regenerative medicine: the emergence of an industry

2010 ◽  
Vol 7 (suppl_6) ◽  
Author(s):  
Robert M. Nerem
Keyword(s):  
Tissue Engineering ◽  
Regenerative Medicine ◽  
Private Sector ◽  
Medical Device ◽  
Engineering Industry ◽  
Full Time ◽  
Business Units ◽  
The World ◽  
The Future ◽  
Pharmaceutical Industries

Over the last quarter of a century there has been an emergence of a tissue engineering industry, one that has now evolved into the broader area of regenerative medicine. There have been ‘ups and downs’ in this industry; however, it now appears to be on a track that may be described as ‘back to the future’. The latest data indicate that for 2007 the private sector activity in the world for this industry is approaching $2.5 billion, with 167 companies/business units and more than 6000 employee full time equivalents. Although small compared with the medical device and also the pharmaceutical industries, these numbers are not insignificant. Thus, there is the indication that this industry, and the related technology, may still achieve its potential and address the needs of millions of patients worldwide, in particular those with needs that currently are unmet.

3D bioprinting for meniscus tissue engineering: a review of key components, recent developments and future opportunities

2021 ◽  
Author(s):  
Xavier Barceló ◽  
Stefan Scheurer ◽  
Rajesh Lakshmanan ◽  
Cathal J Moran ◽  
Fiona Freeman ◽  
...  
Keyword(s):  
Tissue Engineering ◽  
Regenerative Medicine ◽  
Meniscal Repair ◽  
Spatial Patterning ◽  
3D Bioprinting ◽  
Research Areas ◽  
Engineered Tissues ◽  
Meniscal Tissue ◽  
Meniscus Tissue ◽  
Recent Developments

3D bioprinting has the potential to transform the field of regenerative medicine as it enables the precise spatial patterning of biomaterials, cells and biomolecules to produce engineered tissues. Although numerous tissue engineering strategies have been developed for meniscal repair, the field has yet to realize an implant capable of completely regenerating the tissue. This paper first summarized existing meniscal repair strategies, highlighting the importance of engineering biomimetic implants for successful meniscal regeneration. Next, we reviewed how developments in 3D (bio)printing are accelerating the engineering of functional meniscal tissues and the development of implants targeting damaged or diseased menisci. Some of the opportunities and challenges associated with use of 3D bioprinting for meniscal tissue engineering are identified. Finally, we discussed key emerging research areas with the capacity to enhance the bioprinting of meniscal grafts.

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.

scholarly journals The Brazilian sectoral innovation system in the field of Tissue Engineering and Bioprinting: actors, challenges and perspectives

2019 ◽  
Vol 2 (1) ◽  
pp. 33
Author(s):  
Pedro Xavier Rodriguez Massaguer ◽  
Ana Luiza Garcia Massaguer Millás
Keyword(s):  
Tissue Engineering ◽  
Additive Manufacturing ◽  
Regenerative Medicine ◽  
Innovation System ◽  
Innovation Systems ◽  
3D Bioprinting ◽  
System Framework ◽  
Medium Term ◽  
History Of ◽  
Systems Framework

The objective of this work is to map the main actors within the Brazilian innovation system framework in the field of tissue engineering and bioprinting, and analyze the main conditioners related to entrepreneurship and innovation. While keeping as a backdrop, the history of 3D Biotechnology Solutions startup, its challenges and projects. Tissue engineering is a subcategory of regenerative medicine with the purpose of repairing or substituting, partially or completely, tissues or organs that have been affected by some disease or lesion. The conventional methods used for the production of these biomaterials via tissue engineering do not have the capacity to mimic the reality of native structures in the nano, micro and macro scales, while guaranteeing the reproducibility andscalability ofthematerials. Technologies such as 3D bioprinting or additive manufacturing could change the way that many diseases are treated in the medium term by replacing the damaged tissues with custom bio-similar constructs. Mapping and reflections based on the innovation systems framework contribute to organize stimulus policies, stimulate interaction between actors, identify gaps and technological demands and periodically organize the analysis and expansion of this system in Brazil.

Exploring Solutions to Foster ATMP Development and Access to Patients in Europe

2020 ◽  
Vol 27 (3) ◽  
pp. 259-273
Author(s):  
Vincenzo Salvatore
Keyword(s):  
Research And Development ◽  
Success Rate ◽  
Critical Factors ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Legislative Reform ◽  
Eu Regulation ◽  
Advanced Therapy ◽  
The Eu

Abstract There are several critical factors that have influenced the (un)success rate of advanced therapy medicinal products (ATMPs) over the first ten years since the EU Regulation 1394/2007 entered into force. This article provides an overview of the current regulatory scenario and outlines the outstanding challenges to be faced in order to further promote research and development of ATMPs and the issues to be considered in the perspective of a possible legislative reform.

Nanomaterials for bioprinting: functionalization of tissue-specific bioinks

2021 ◽  
Author(s):  
Andrea S. Theus ◽  
Liqun Ning ◽  
Linqi Jin ◽  
Ryan K. Roeder ◽  
Jianyi Zhang ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Tissue Engineering ◽  
Regenerative Medicine ◽  
Biomedical Applications ◽  
Disease Modeling ◽  
Three Dimensional ◽  
3D Bioprinting ◽  
Significant Step ◽  
Printing Processes

Abstract Three-dimensional (3D) bioprinting is rapidly evolving, offering great potential for manufacturing functional tissue analogs for use in diverse biomedical applications, including regenerative medicine, drug delivery, and disease modeling. Biomaterials used as bioinks in printing processes must meet strict physiochemical and biomechanical requirements to ensure adequate printing fidelity, while closely mimicking the characteristics of the native tissue. To achieve this goal, nanomaterials are increasingly being investigated as a robust tool to functionalize bioink materials. In this review, we discuss the growing role of different nano-biomaterials in engineering functional bioinks for a variety of tissue engineering applications. The development and commercialization of these nanomaterial solutions for 3D bioprinting would be a significant step towards clinical translation of biofabrication.

scholarly journals PPM11 Market Access Landscape for Advanced Therapy Medicinal Products in the EU-5

2020 ◽  
Vol 23 ◽  
pp. S688-S689
Author(s):  
F. Benazet ◽  
I. Berard ◽  
M. Prada ◽  
A. Ricci ◽  
S. Walzer ◽  
...  
Keyword(s):  
Market Access ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Advanced Therapy ◽  
The Eu
Sign in / Sign up

Export Citation Format

Share Document