Medical Device Directive Research Articles

Response to the letter from Una Adderley Journal of Wound Care (JWC).' August 2019.

Journal of Wound CareVol. 28, No. 9 Letters on Generic Product SpecificationFree AccessResponse to the letter from Una Adderley Journal of Wound Care (JWC).’ August 2019Richard WhiteRichard WhiteProfessor of Tissue Viability and Director, DDRC PlymouthSearch for more papers by this authorRichard WhitePublished Online:12 Sep 2019https://doi.org/10.12968/jowc.2019.28.9.564aAboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail The open letter submitted by Adderley is most welcome, especially at this stage in events. Many involved in wound care have been of the opinion that the NWCSP work to aid or support the supply of wound care products had already begun and that the ‘irregularities’ involved in the ongoing e-tendering process were, in some way, attributable to their advice. Adderley's letter now makes it clear that this is not the case. However, any existing link between the NWCSP and the NHS Clinical Evaluation Team needs to be made clear.Thus, when we see glaring anomalies between NHS Supply Chain product selection for the superabsorbent polymer category and the report of the ‘NHS Clinical Evaluation Team’ of October 2018 we may be certain that the contents of this report have not been used in decision making. For those who may be unaware of the existing reports which are in the public domain, they can be accessed at https://wwwmedia.supplychain.nhs.uk/media/Clinical-Review-for-Superabsorbent-Dressings-October-2018.pdfThe report on SAPs identifies one product which was made available without an ‘instructions for use document’ (IFU). This is a legally mandatory requirement for a class IIb device according to the Medical Device Directives. Furthermore the same product was scored as zero stars out of three for the criterion of ’the dressing maintains integrity when fluid is absorbed’. That a product which fails these important criteria be included in an NHS Supply Chain list of available products is beyond comprehension. It cannot be argued that the use of such products facilitates ‘excellence in wound care’. Clinicians, patients, and purchasers who may read this letter should take note that this is what the NHS Supply Chain now offers!The involvement of the NWCSP to introduce wound care expertise and commonsense advice into the process to avoid such situations is most welcome, the sooner it is fully operational the better. FiguresReferencesRelatedDetails 2 September 2019Volume 28Issue 9ISSN (print): 0969-0700ISSN (online): 2052-2916 Metrics History Published online 12 September 2019 Published in print 2 September 2019 Information© MA Healthcare LimitedPDF download

Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective

On 26 May 2017, the Medical Devices Regulation (MDR 2017/745) was published, with the aim of replacing the current Medical Devices Directive (MDD 93/43/EC). Following a transition period of 3 years, this regulation will be applied in full from 26 May 2020. This article describes and discusses the impact of MDR on the clinical evaluation and gives advice to manufacturers on the preparation, planning and implementation of processes to support compliance with the new regulation. (Market Access)

Is health-care data the new blood?

Is health-care data the new blood?

Regulating Certification Bodies in the Field of Medical Devices: The PIP Breast Implants Litigation and Beyond

This article uses the breast implants scandal around the French producer Poly Implant Prothèse (PIP) to discuss the regulation of medical devices in EU law. Thereby, the specific focus is on the role of tort liability of certification bodies in complementing the public law regime of medical devices law. As tort law has not been harmonized yet at the level of EU law, national legal systems may produce different results; which indeed the PIP case demonstrates, with diverging judgments from French and German courts. Showing the deficiencies of the public law system of the Medical Devices Directive of 1993 as well as of the new Medical Devices Regulation of 2017, the article argues that tort liability is a necessary regulatory instrument to ensure that certification bodies live up to their duties under medical devices law and therefore a necessary instrument for the protection of the health and safety of patients.

PP31 Medical Device Regulation: What Is New?

IntroductionIn 2017, the European Union (EU) commission released the final versions of the Medical Device Regulation (MDR) and In-vitro Diagnostic Device Regulation. These regulations will replace the EU directives (Medical Device Directive [MDD], In-vitro Diagnostic Device [IVDD], and Active Implantable Medical Device [AIMD]). EU regulations are effective in all EU countries at date of publication. In contrast, the EU directives must be implemented in national law first.MethodsGuidelines and respective legislation, consultation results and methods/medical device (MD) evaluations were reviewed and analyzed. Decision criteria and reasoning, assessment outcomes and potential impact on price negotiations were the main aspects for comparison.ResultsManufacturers have to be aware of the importance of clinical data for demonstrating the compliance of their products. This applies both to the approval of the products and the “post-market activities” and particularly to the “post-market clinical follow-up” for which requirements for Class I and II products need to be further developed. The MDR requires manufacturers to collect clinical data before and after approval, which could lead to excessive documentation requirements. The term “sufficient clinical data” from the MDR is unclear. A functional Eudamed specification is necessary, which enables an automated processing of relevant data. A stronger involvement in the evaluation process is needed as well as more transparency in the Joint Federal Committee (G-BA) and faster evaluation processes.ConclusionsThe MDR increases the burden especially for small businesses, and it is doubtable that the ultimate goal – improving patient safety – will be achieved. The increased demands and rising costs of the new EU MDR and bottlenecks at Notified Bodies can be a risk for the MD industry. Due to the general reduction in the remuneration for services with a high proportion of technical services, it is feared that products will be withdrawn from the market for economic reasons or that they will not be marketed.

In-depth review on ‘innovation and regulatory challenges of the drug delivering medical devices’

The medical device market is generally seen as an area with high growth potential and provides greater profit margins including significant positive benefits to the patients. As the medical device regulations and the guidance document are becoming stringent in the US, manufacturers of these types of products are now facing these conundrums along with a need for clarification on matters related to various drug and device provisions. The European Union is making major changes to the Medical Device Directive which is its regulatory scheme for devices. Some parts are focused on the medical devices. The new changes in the regulations represent an important step forward in the growing philosophy of medical devices in Europe. Along with the regulatory challenges, there are various challenges faced during the innovation of such products. There are many factors that affect innovation including the patent aspects. In general, the key thing is that small firm face lots of difficulty compared to larger firm in bringing medical device in market. Thus, the proposed manuscript focuses on understanding the regulatory issues in various countries for ease of innovation and marketing authorization of medical devices.

Challenges of Medical Device Regulation for Small and Medium sized Enterprises

Abstract For known reasons, the European Parliament was forced not only to revise the old Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), but to replace it with the extensive MDR. With the implementation of the Medical Device Regulation (MDR) in May 2017, manufacturers of medical devices will face new challenges for their products in the future, which also have to be implemented in a timely manner. Particularly small and medium-sized enterprises (SMEs) are concerned about whether a timely adaptation to the MDR and their requirements can be implemented. The conversion is associated with a huge effort for all producers of medical devices and certainly, produkt launchers. The purpose of this paper is to get an overview of the most relevant and emerging requirements that manufacturers need to adapt to sell their medical devices in compliance with the MDR regulations. It also explains the extent to which changes and innovations in the MDR are discusses and problems for SMEs.

OA198] Evaluation of the needs for PPV measurement from the legal point of view

Purpose The main aim of the study is to evaluate whether it is mandatory to have QA device (D&IR Diagnostic & Interventional Radiology application) with possibility of PPV (Practical Peak Voltage) measurement. The secondary aim of the study is to find weather all available measuring devices on the European market provide all necessary readings. The Purpose of the study do not cover investigation whether PPV measurements should be used instead of kVp measurements. Methods European regulation has been verified. Evaluation and comparison of existing devices on the marked has been performed. Results On the European market all device uses in medical sector should be CE marked and should meet requirements of Medical Device Directive 93/42/EEC. There is a list of international standards harmonized with MDD directive, which means that if any device is covered by any of those standards, the specified medical device must meet additional requirements. One of such a standard is EN 61676:2002 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology IEC 61676:2002, which provide need of PPV (practical peak voltage) measurements, however it is common in practice to choose kVp measurements rather than PPV. 5 main leading European manufacturers has been evaluated. 4 manufacturers offer device with possibility of PPV measurement, while one vendor do not give user possibility to choose PPV instead of kVp if needed. This vendor provide only devices with kVp measurements, nevertheless the devices are CE marked. Conclusions It has been found that from European regulation point of view the devices uses for QA in D&IR purposes should has possibility of PPV measurement to fulfill requirements of MDD Directive due to harmonized standard EN-IEC 61676:2002. Some of the devices existing on the market, provided by leading vendor, do not meet MDD requirements, therefore their legal use for the QA purposes in D&IR might be questionable. It is also very interesting that the device without PPV possibility is CE marked, probably international organizations like COCIR could check the quality of external audits during CE marking process.

Pie in the sky when you die? Civil liability of notified bodies under the Medical Devices Directive: Schmitt

Pie in the sky when you die? Civil liability of notified bodies under the Medical Devices Directive: <i>Schmitt</i>

A Review on European Union New Medical Device Regulations-2017

The New Medical Device Regulations of European Union replace the E.U’s current Medical Device Directive (93/42/EEC) and the E.U’s Directive on Active Implantable Medical Devices (90/385/EEC) According to the draft document, NB’s would be placed under a strict regimen of super vision, although it remains unclear whether the intended sanctions could be implemented against the will of a Member State, should the need occur. The qualification requirements for auditing and reviewing NB staff are steeply increased. Greater emphasis will be placed on clinical data and the Clinical Evaluation. For implantable medical devices and Class III devices clinical investigations will be expected since equivalence will generally no longer be an acceptable approach, although some exceptions can be made. The proposed MDR attempts to make more transparent the periods for review by various parties for different activities. Implementation of Unique device identification helpful for the unambiguous identification of a specific device on the market.

ASSESSING THE VALUE OF INNOVATIVE MEDICAL DEVICES AND DIAGNOSTICS: THE IMPORTANCE OF CLEAR AND RELEVANT CLAIMS OF BENEFIT.

Large numbers of new medical devices and diagnostics are developed and health services need to identify which ones offer real advantages. The National Institute for Health and Care Excellence (NICE) has introduced a system for assessing technologies that are often notified by companies, based on claims made for their benefits to patients, the National Health Service, and the environment. Detailed scrutiny of claims made for the benefits of products and the corresponding evidence, seeking associations between these and the selection of products for full evaluation to produce NICE guidance. Between 2009 and 2015 a NICE committee considered 169 technologies, of which it selected 74 (44 percent) for full evaluation, based on the claims of benefit and the evidence available. An average of 7.5 claims were made per technology; the total number did not influence selection but presence of studies supporting all the claims (p < .001) or any of the claims (p < .05) had a positive influence, as did claims for quicker patient recovery (p < .001). A greater number of studies to support the claims made selection more likely (p < .001), as did cohort studies (p < .05) and surveys (p < .05) but, unexpectedly, not randomized trials. The Medical Device Directive class had no influence. This study presents categories of claims that may be useful to those developing new products and to others engaged in health technology assessment. It illustrates the importance of relevant evidence and of having a clear vision of the place of new products in care pathways from an early stage.

Quality Assurance in Custom Dental Devices: A Technologist's Perspective.

Manufacturing of custom-made dental devices such as removable dentures, fixed prosthodontics and orthodontics are subject to the requirements of the Medical Devices Directive (MDD). Many dental laboratories often enhance these requirements by implementing quality assurance procedures that then provide enhanced consistency. this paper provides a dental technologist's view of some of the systems currently being used in dental laboratories to provide a quality assured product and associated issues.

New European Medical Device Directive (MDD) Comes Into Effect In 2020: Chances And Consequences For Stakeholders

Despite high requirements for approval of medical devices (MDs), several serious and avoidable complications caused by product specific quality deficiencies were observed during the past years. To ensure that all MDs (all classes ranging from heart valves to sticking plasters) are safe, the EU commission proposed in 2012 new regulations on medical and in-vitro diagnostic MDs (e.g. extending the market surveillance, verifying scientific and technological evidence). To assess the effect of the new MDD on four different stakeholders (i.e. manufacturers, regulatory bodies, physicians, and patients) a decision analytical framework has been used. Based on a structured analysis the strengths, weaknesses, opportunities and threats of the new MDD have been identified and a qualitative analysis of their occurrence rates was performed. The most often expected consequences by implementing the new MDD are the increased workload and higher product development costs for manufactures, but also an enhanced product safety for patients, higher quality of medical evidence to the attention of regulatory bodies and physicians. Outcomes occurring less often as a consequence of the implementation of the new MDD are a decline of new and innovative products for diseases with a limited profitability or a reduction of small and mid-size manufacturers of MDs either due to buy up by bigger companies or by abandoning the business area. Overall, the implementation of the new MDD results in a benefit for all stakeholders. Nevertheless, an extended regulation causes also unfavorable consequences. Even though the implementation of the new rule will come into effect in 2020, it is important that all stakeholders anticipate the wide range of potential consequences as early as possible. Therefore, the findings of the decision analytical framework may help to identify areas with a high impact and to develop strategic decisions.

Heart Rate Monitoring Apps: Information for Engineers and Researchers About the New European Medical Devices Regulation 2017/745

Background: After years in the making, on April 5, 2017, the European Parliament and Council finally adopted Regulation (EU) 2017/745, the new Medical Devices Regulation (MDR), repealing the existing Medical Device Directive (MDD) 93/42/EEC. Though long anticipated, this shift in policy will have strong and lasting effects in the medical devices industry.

Reporting medical device safety incidents to regulatory authorities: An analysis and classification of technology-induced errors.

The European Union Medical Device Directive 2007/47/EC1 defines software with a medical purpose as a medical device. The implementation of health information technology suffers from patient safety problems that require effective post-market surveillance. The purpose of this study was to review, classify and discuss the incident data submitted to a nationwide database of the Finnish National Competent Authority with other forms of data. We analysed incident reports submitted to the authority database by users of electronic health records from 2010 to 2015. We identified 138 valid reports. Adverse events associated with electronic health record vulnerabilities, clustered around certain error types, cause serious harm and occur in all types of healthcare settings. The low rate of reported incidents raises questions about not only the challenges associated with medical software oversight but also the obstacles for reporting.

Performance of the SAMBA I and II HIV-1 Semi-Q Tests for viral load monitoring at the point-of-care

Although access to antiretroviral therapy for HIV infection is increasing in resource-poor countries, viral load testing for monitoring of treatment efficacy remains limited, expensive, and confined to centralized laboratories. The SAMBA HIV-1 Semi-Q Test is a nucleic acid–based amplification assay developed for viral load monitoring performed on either the semi-automated SAMBA I system for laboratory use or the fully automated SAMBA II system for point-of care use. We have assessed the performance characteristics of the SAMBA HIV-1 Semi-Q Test on SAMBA I and SAMBA II systems according to the Common Technical Specifications of the European Community's 98/79 In Vitro Diagnostic Medical Devices Directive. The sensitivity, specificity, reproducibility, and viral subtype coverage of the test were similar on the SAMBA I and SAMBA II platforms. The clinical performance on the SAMBA I system was compared with the Roche CAP/CTM assay and evaluated in-house with 130 patient specimens from London as well as in the field with 390 specimens in Kenya and Zimbabwe. The overall concordance between the SAMBA and CAP/CTM assays was 98.1%. The clinical performance of the test on the SAMBA II platform in comparison with the Abbott HIV-1 RealTime Assay was evaluated in-house with 150 specimens from Ukraine, yielding a concordance of 98.0%. The results thus show that the SAMBA HIV-1 Semi-Q Test performs equivalently on SAMBA I and SAMBA II, and they suggest that the test is suitable for implementation at the point-of-care in resource-poor regions where viral load testing is desperately needed but often unavailable.

Concept for a National Implant Registry to Improve Patient Safety

Since the introduction of silicone implants, several events have led to considerable uncertainty among the patients, public, and users. So far, however, the necessary steps to significantly improving patient safety have not been taken in any of these cases. Requiring stricter approvals for medical devices, improving monitoring by the regulatory authorities and the revision of the Medical Devices Directive are all initial steps in the right direction towards a change in policy, but are insufficient as an early warning system. After the introduction of registers was announced in the coalition agreement, the German Society of Plastic, Aesthetic and Reconstructive Surgeons (DGPRÄC), in close consultation with the Ministry of Health, has developed a concept which is presented here. The need for a uniform and legally binding central register for breast implants is fully supported by the entire medical profession. According to the concept presented by the DGPRÄC, three data qualities would be applicable: Safety data (mandatory), physician information (voluntary) and research data (optional, except if safety related). The public authorities are creating a unified, secure entry portal for all professional associations concerned. This register is based with the professional associations, and from there the mandatory security data will be forwarded to the public authorities. Decoding of the identity of the patient and doctor would only occur in specifically defined emergency situations such as product recalls. Automated tools in the security database provide early detection of problems, so that rapid clarification is possible in consultation with the professional associations, manufacturers and possibly patients. This concept as proposed by the DGPRÄC has thus far been very positively received in all discussions between the various parties concerned.

TŁUMACZ PRZYSIĘGŁY A DYREKTYWY: TERMINOLOGICZNE WYZWANIA ZWIĄZANE Z TŁUMACZENIEM DYREKTYWY DOTYCZĄCEJ WYROBÓW MEDYCZNYCH

The presentation addresses the field of translating EU texts (directives), specifically the Medical Device Directive. The translation of EU instruments lies within the scope of responsibilities of the translators working for the European Commission and the European Parliament. Yet, sworn translators working in their native countries face the need to translate medical documentation both for natural persons (that is necessary for administrative purposes) and for corporate bodies (that operate on the common European market and require e.g., declarations of conformity, instructions for use or EC design examinations certificates to commercialise their products and thus run their business). Naturally, sworn translators while performing tasks commissioned refer to and consult the accepted translated versions of EU instruments to remain in line with the versions that have been transposed into their national legislations. In this paper, the original (English) and the translated (Polish) versions of the Medical Device Directive (93/42/EEC) shall be compared and analysed to find whether the Polish version fully reflects assumed terminological consistency.

Abstracts from ATTD 2016 9th International Conference on Advanced Technologies & Treatments for Diabetes Milan, Italy-February 3-6, 2016.

Abstracts from ATTD 2016 9th International Conference on Advanced Technologies & Treatments for Diabetes Milan, Italy-February 3-6, 2016.

Credibility and Confidence in Your Dental Laboratory Work-How Quality Assurance Systems Can Be Used in the Manufacturing of Individual Custom-Made Dental Devices.

Manufacturing of custom-made dental devices such as removable dentures, fixed prosthodontics and orthodontics are subject to the requirements of the Medical Devices Directive (MDD). Many dental laboratories often enhance these requirements by implementing quality assurance procedures that then provide enhanced consistency. This paper provided a personal view of some of the systems currently being used in dental laboratories to provide a quality assured product and associated issues.