European Medical Devices Regulation (MDR)

 
REGULATION (EU) 2017/...
OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
of ...
on medical devices, amending Directive 2001/83/EC,
Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
and repealing Council Directives 90/385/EEC and 93/42/EEC
 
 

The new Regulations on medical devices

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 in a nutshell

The new Regulations contain a series of extremely important improvements to modernise the current system. Among them are:

  • stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level;
  • the reinforcement of the criteria for designation and processes for oversight of Notified Bodies;
  • the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations;
  • the introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance;
  • improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification;
  • the introduction of an “implant card” containing information about implanted medical devices for a patient;
  • the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
  • the strengthening of post-market surveillance requirements for manufacturers;
  • improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance. 

 

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:

 

  • Regulation on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

 

 

The main reasons behind this change

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:

  • a consistently high level of health and safety protection for EU citizens using these products
  • the free and fair trade of the products throughout the EU
  • that EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years.

 

Source: http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_en

 
 
Dr. Hekmat CONSULTING

Consulting   & Interim Management

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

www.hekmat-consulting.de

 

USt-ID Nr.: DE295239280

 

Im Brühl 10/1, 72144 Dusslingen, Germany  (Stuttgart area)

Email: anusch.hekmat@gmail.com

Mobile: +49 170 8530715

Skype: anuschirawan.hekmat

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