On 5 April 2017, 2 new Regulations on medical devices (a Regulation on medical devices and a Regulation on in-vitro diagnostic medical devices) were adopted. These replace the existing Directives.
The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
The Commission welcomes the adoption of its proposal for 2 Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.
The new Regulations contain a series of extremely important improvements to modernise the current system. Among them are:
More information is available in this presentation that contains general information on key changes contained in the Regulations and transitional periods.
The final adopted texts are expected to be published in the Official journal early May. In the meantime the final texts of the Regulations as voted by the Council and the European Parliament are available here:
Problems with diverging interpretation of the current Directives as well as some incidents with breast implants and metal hips highlighted the weaknesses of the current legal system and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. Such problems should not occur again and the safety of all medical devices available in the EU has to be strengthened. Moreover, revision of the legislation was necessary to consolidate the role of the EU as a global leader in the sector over the long-term and to take into account all technological and scientific developments in the sector.
The new regulations will ensure:
Quality Management & Regulatory Affairs Medical Devices & Combination products
Since 1994, effective Strategic & Operative experience in Quality Management & Regulatory Affairs for Medical Devices industry, within the fields of Ophthalmology, Neuro-stimulation, Vascular Intervention, Cardiology, Heart Surgery, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, CT & NMR digital Imaging (3D), and in vitro Diagnostics.
Technical Documentation (DHF, DMR, DHR) including Analysis & Evaluation of Product Function & Safety, Biocompatibility, Packaging, Labeling (UDI), Sterilization, Laboratory results, Software & Hardware.
Compliance to applicable Standards (ISO, IEC, EN, MIL).
Manufacturing Process Verification, Validation (IQ, OQ, PQ).
Product & Production-process Risk Management (Risk Analysis & Risk Control), including Additive Manufacturing.
Clinical Evaluation, Organization of global multicenter Clinical Studies.
Audits of Production Processes & Suppliers.
Medical Device Reporting to Competent Authorities (e.g. BfArM, FDA).
Corrective And Preventive Action (CAPA) / Non-Conformity (NC) / corrective Project.
On site Support in Notified Body audits, and FDA inspections.
Effective management leading to a multitude of marketing approvals in the EU, Americas (FDA), & Asia, including Reimbursement schemes.
Dr. Hekmat CONSULTING
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