NEWS on implant administration

2 million joint replacement surgeries recorded in the german endoprosthesis register

A Road Map To China’s Medical Device Registration Process

Active Surveillance of Medical-Device Safety

Avoid Compliance & Timeline Risks Whith Medical Device Supplier


Breast implant tourism in Tunesia

Canada acts on Implant Files

CANADA: Medical Device Single Audit Program Transition Plan

Changes to ISO 13485 2016 for Medical Device Manufacturers, Designers

China Regulation of Medical Devices

Clinical Evaluation Reports under the EU MDR

Compliance with legal requirement to report clinical trial results on ClinicalTrials

Concerns about shortages of orthopaedic implants due to the EU Medical Device Regulation

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

Criminals fake implants with 3-D-tools

Dental companies to make changes to their product range

Dental Implant Software – List

Dental Implants in Times of Coronavirus

Deutsches Implantateregister soll 2023 in Betrieb gehen (german text)

Digital Health Innovation Plan (FDA)

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

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

EU CED: Implant certificate for dental implants (passport)

EU CED: Implantatpass für Zahnimplantate

EU Commission wants to establish a Europe-wide network of health data

EU intends to postpone medical devices regulation by one year

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

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

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

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

Eudamed database: Registration as economic operator possible from 01.12.20

Europe: Authorities judge cancer danger at breast implants differently

Europe: Dental companies to make changes to their product range

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

European Commission names UDI Issuing Agencies

Examining FDA’s New Patient Labeling Draft Guidance

FDA: Known risk of lymphoma from breast implants

FDA: Reporting Allegations of Regulatory Misconduct

FDA: Unique Device Identification

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

GDPR and Medical Devices

Genium knee joint – insurance (german)

German government decides on a national implant patient registry

German implant registry goes into trial operation

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

German Ministry of Health announces national Implant-Register

German Orthopaedists demand expertise for implant register (german)

German state implant registry will not go active before 2023

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

Germany: Health insurance fund does not have to pay for breast augmentation for psychological reasons

Germany: Specialty association certifies cochlear implant centers

Green light for transplant registry in Germany

How the EU Commission nationalizes health data

How To Prepare For An FDA Inspection

Implications Of COVID-19: EU MDR Implementation Update

India To Regulate All Medical Devices

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

More pragmatic randomized studies with a focus on registry-based trials

Number of cosmetic surgeries on the rise (Germany)

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

Paris court awards compensation to women for faulty breast implants

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

Platform for testing, development and approval of cardiovascular implants planned

Registries of implantable medical devices in Europe

Regulation on Medical Devices Europe (MDR) causes unrest

Reorientation of independent patient counseling in Germany

Standard Of Care And The Internet Of Medical Things

The doctor-patient relationship and the commercial use of health data in the EU

The European MDR: Impetus, Impacts, And Current Status

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

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