NEWS on implant administration

2 million joint replacement surgeries recorded in the german endoprosthesis register

Ten years after its launch, the Endoprosthesis Register Germany (EPRD) has now surpassed the two-million mark in the recording of surgical documentation. This can be a reliable database for assessing hip and knee endoprosthetic care in Germany. The voluntary data supplied by more than 780 hospitals cover more than 70...

A Road Map To China’s Medical Device Registration Process

China has one of the most promising medical markets and its healthcare industry is currently the second largest in the world, following closely behind the U.S. From 2015 to 2019, the CAGR for the Chinese medical devices market has increased significantly, and it is expected to continue rising even more in the...

Active Surveillance of Medical-Device Safety

Registry-Based Prospective, Active Surveillance of Medical-Device Safety Resnic FS, Majithia A, Marinac-Dabic D, Robbins S, Ssemaganda H, Hewitt K, Ponirakis A, Loyo-Berrios N, Moussa I, Drozda J, Normand S-L, Matheny ME A strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial...

Avoid Compliance & Timeline Risks Whith Medical Device Supplier

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BIOCOMPATIBILITY OF PLASTICS

  The International Organization for Standardization (ISO) presents widely adopted medical device guidelines that are aimed with a keen focus towards risk management. Biocompatibility testing for these devices and device components is addressed by ISO standard 10993. RESINATE 2017 Well-defined material characterization is a fundamental requirement in biocompatibility assessment. This...

Breast implant tourism in Tunesia

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Canada acts on Implant Files

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CANADA: Medical Device Single Audit Program Transition Plan

CANADA: Medical Device Single Audit Program Transition Plan (FAQ) Health Canada clarification about the MDSAP Transition Plan from stakeholders as Health Canada moves towards the Medical Device Single Audit Program (MDSAP) Quality Systems Division, Medical Devices Bureau, Health Canada

Changes to ISO 13485 2016 for Medical Device Manufacturers, Designers

Published early in 2016, ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes establishes a new international framework to mitigate risk and produce effective medical devices. Christine Berard As the new standard now clarifies that a company’s QMS “shall meet customer and applicable regulatory requirements for...

China Regulation of Medical Devices

Global Impact: China's Regulations On The Supervision And Administration Of Medical Devices Yin A, Guo T, Rong M, Yang L, Smith R As China’s National Medical Products Administration (NMPA) moves closer to finalizing its 2018 draft Amendments to the Regulations on the Supervision and Administration of Medical Devices, medical device...

Clinical Evaluation Reports under the EU MDR

Understanding Clinical Evaluation Reports under the EU MDR D Egbosimba Every medical device sold into Europe, new or existing, and irrespective of specification, must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File. The manufacturer also needs to demonstrate that the device achieves its intended purpose...

Compliance with legal requirement to report clinical trial results on ClinicalTrials

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COVID-19 (SARS-CoV-2, Coronavirus) – LINKS

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Criminals fake implants with 3-D-tools

Darum gefährden 3-D-Drucker unsere Gesundheit Die Welt, Germany Criminals fake implants, protheses and pacemaker with 3-D-tools Carsten Dierig

Dental companies to make changes to their product range

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Dental Implant Software – List

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Dental Implants in Times of Coronavirus

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Deutsches Implantateregister soll 2023 in Betrieb gehen (german text)

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Digital Health Innovation Plan (FDA)

FDA can help encourage digital health innovation by redesigning our policies and processes and modernizing our tools so that they match the needs of digital health technology, and providing clarity on those policies and processes so that manufacturers and developers know what they need to do. We have designed this...

Empfehlung für die Verwendung von Paclitaxel-beschichteten Stents (DES) und Ballons (DCB) in der Behandlung der peripheren arteriellen Verschlusskrankheit (pAVK) (german)

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ESC/EACTS Guidelines for the management of valvular heart disease 2017

2017 ESC/EACTS Guidelines for the management of valvular heart disease European Heart Journal, Volume 38, Issue 36, 21 September 2017, Pages 2739–2791 The Task Force for the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) The disclosure forms...

EU CED: Implant certificate for dental implants (passport)

The Council of European Dentists decided in 2020 that, according to the Medical Devices Regulation, an implant passport must be given to a patient. This should clearly identify the implant. Healthcare providers will be obliged to provide patients with such a passport. Implant Register: The easiest way is to download...

EU CED: Implantatpass für Zahnimplantate

Das Council of European Dentists beschloss, dass gemäß Medizinprodukteverordnung einem Patienten ein Implantatpass auszuhändigen ist. Dieser soll das Implantat eindeutig identifizieren. Gesundheitsdienstleister werden verpflichtet den Patienten einen solchen Ausweis auszuhändigen. Implant-Register: Der einfachste Weg ist es, den Implantatpass im Register herunterzuladen und auszudrucken. Der download ist hier.

EU intends to postpone medical devices regulation by one year

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EU Medical Device Regulation (MDR) with far-reaching impact for device manufacturers doing business in Europe

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EU parliament postpones Medical Devices Regulation (MDR) for one year.

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EU-Medizinprodukte-Verordnung – MDR 2020: Was erwartet Zahnärzte (Red.: Einführung auf 2021 verschoben) (german)

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EU: Use of Symbols to Indicate Compliance with the Medical Devices Regulation

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Eudamed database: Registration as economic operator possible from 01.12.20

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Europe: Authorities judge cancer danger at breast implants differently

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Europe: Dental companies to make changes to their product range

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Europe: Patient care with innovative medical products will become more difficult

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European Commission names UDI Issuing Agencies

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Examining FDA’s New Patient Labeling Draft Guidance

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FDA: Known risk of lymphoma from breast implants

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FDA: Reporting Allegations of Regulatory Misconduct

The FDA encourages people submitting allegations to include supporting information and contact information in case additional information is needed for the FDA to understand the allegation and act on the report; however you can choose to submit a report anonymously. The FDA will not share your identity or contact information...

FDA: Unique Device Identification

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FDA’s “Data Effect” Tsunami – Steps To Prepare

The FDA is moving forward with its Data Modernization Action Plan (DMAP), the next leg of the Technology Modernization Action Plan (TMAP). Announced on March 3, 2021, DMAP is the agency’s overhaul of technology and data with the objective of bringing together increasingly disparate and diverse data sources to help understand and pinpoint emerging...

GDPR and Medical Devices

What Is GDPR's (General Data Protection Regulation) Effect On Medical Devices? K Barchie Rights provided to data subjects reinforced via GDPR are: The right to be informed of the type of processing of their data that will be taking place The right to access and review the data that is...

Genium knee joint – insurance (german)

Krankenkasse muss Kosten für Genium-Kniegelenk tragen Hessisches Landessozialgericht Das LSG Darmstadt hat entschieden, dass ein 82-jähriger Versicherter einen Anspruch auf eine Versorgung mit einem Genium-Kniegelenk anstelle mit einem C-Leg-Beinprothesensystem haben kann, wenn ihm das kostenaufwändigere Hilfsmittel einen wesentlichen Gebrauchsvorteil im Vergleich zur kostengünstigeren Alternative bieten kann, den er auch tatsächlich...

German government decides on a national implant patient registry

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German insurance companies enter into a framework agreement for quality assurance of knee and hip prostheses

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German Ministry of Health announces national Implant-Register

German Ministry of Health announces law for national implant-register Ärzteblatt Following an inquiry of the german party FDP the ministry of health in Germany announced a blueprint for an implant-register to improve reliability of implants and medical treatment. This is a post of a scientific or business information. The information...

German Orthopaedists demand expertise for implant register (german)

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German state implant registry will not go active before 2023

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Germany (MDR): Every third medical technology company fears for its existence.

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Germany: Specialty association certifies cochlear implant centers

According to the professional association, around 50,000 people in Germany are deaf, and another 250,000 have at least a 50 percent hearing impairment. If sufficient understanding of speech is not possible with a hearing aid, a CI can restore hearing and understanding in many cases. A CI is not an...

Green light for transplant registry in Germany

Grünes Licht für Transplantationsregister Dtsch Arztebl 2016; 113(29-30): A-1361 / B-1149 / C-1129 German politics agreed to install a transplant register. Richter-Kuhlmann, E-A.

How To Prepare For An FDA Inspection

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Implications Of COVID-19: EU MDR Implementation Update

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India To Regulate All Medical Devices

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Modernizing FDA’s program for the safety and effectiveness of medical devices

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Number of cosmetic surgeries on the rise (Germany)

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On Implant-Registries: Implant registries represent an additional benefit for the patient

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Paris court awards compensation to women for faulty breast implants

For years, the now insolvent manufacturer PIP had produced implants that were susceptible to rupture. The testing organization TÜV Rheinland had certified the process. A French court has now granted compensation to the complainants. The Paris Court of Appeal on Thursday condemned the testing organization TÜV Rheinland for lack of...

PIP Poly Implant Prosthesis: German supreme court announces decision for 27.02.2020

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Platform for testing, development and approval of cardiovascular implants planned

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Registries of implantable medical devices in Europe

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Regulation on Medical Devices Europe (MDR) causes unrest

Regulation on Medical Devices Europe (MDR) causes unrest ÄrzteZeitung A deficit of qualified employees and the reduced number of notified bodies could result in a shortage of new registrations, hindering manufacturers to introduce new products. This is a post of a scientific or business information. The information given here is checked...

Standard Of Care And The Internet Of Medical Things

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The European MDR: Impetus, Impacts, And Current Status

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Toothless lower jaw justifies social insurance claim on implants (Germany)

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US to Investigate Health Impact of Nickel, Silicone in Medical Implants

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