EUROPEAN UNION NEW MEDICAL DEVICE REGULATIONS-2017

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ABOUT AUHTORS
U.Swathi lakshmi1,  K.Revathi1 , Dr.P.Shailaja1, Prof.J.Vijaya Ratna1, Blessy A. Daniel2, Dr.Prashanth.S.2
1Andhra University College of Pharmaceutical Sciences, Visakhapatnam
2S3V Vascular technologies Pvt.Ltd, Bangalore

ABSTRACT:
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.

Reference Id: PHARMATUTOR-ART-2562

INTRODUCTION:
Ranging from simple sticking plasters and contact lenses to sophisticated pacemakers and hip replacements, cardiac stents medical devices and in vitro diagnostic medical devices are important to our health and quality of life. People rely on these devices every day and expect them to be safe and incorporate the latest progress in science and innovation. Medical devices within the EU are currently regulated by the following 3 directives
• Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)
• Council Directive 93/42/EEC on Medical Devices (MDD) (1993)
• Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998)

The Commission has adopted several implementing measures based on the Medical Devices Directives and released new medical device regulations. The attempt is made to concentrate the harmonization effects between member states of European union by means of a new regulations body called the Medical Device Coordinate Group (MDCG).The new Regulations on medical and in-vitro diagnostic medical devices proposed by the Commission in 2012 will help to ensure that all medical devices from heart valves to sticking plasters to artificial hips are safe and perform well. To address this, the new rules will improve market surveillance and traceability as well as make sure that all medical devices are designed to reflect the latest scientific and technological state-of-the art. The rules will also provide more transparency and legal certainty for producers, manufacturers, importers, and help to strengthen international competitiveness and innovation in this strategic sector. Compared to medical device Directive  the medical device regulations promotes shifts  from the preapproval stage (i.e. path to CE marking) to life cycle approach.

SIGNIFICANT CHANGES IN FRONT OF MEDICAL DEVICE MANUFACTURER
Medical device manufacturers confronted with major changes in the EU’s decades-old regulatory framework, which governs market access to the European Union (EU). The MDR replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). The Medical Device Regulations in May 26th 2017, the Manufacturer of currently approved medical devices will have a transition period of three years until May 26th 2020 to meet the requirements of the MDR.

 

BELOW IS AN ESTIMATED TIMELINE FOR THE MDR BASED ON CURRENT ASSUMPTIONS.

THE TIMELINES FOR THE MDR

Medical Device Regulation (MDR) published in the Official Journal of the European Union (OJEU)

26th May 2017

Notified Bodies (NBs) may issue certificates under the MDD or AIMDD with a maximum validity of 5 years

26th May 2017 to 26th May 2020

NBs may apply for MDR designation

26th November 2017

Certificates issued in accordance with Annex 4 of AIMDD and Annex IV of MDD (EC-type verifications) that have not yet expired will become void

26th May 2019

Official "Date of application" of the MDR

26th May 2020

MDD Annex IV certificates expire

27th May 2022

Other certificates issued under current Directives that have not yet expired will become void

26th May 2024

Devices that were CE Marked under the MDD or AIMDD may no longer be marketed or put into service in Europe

26th May 2025

The new Regulations contain a series of extremely important improvements to modernize 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;
• 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

KEY CHANGES IN THE NEW MEDICAL DEVICES REGULATIONS, EU
The proposed MDR differs in several important ways from the EU’s current directives for medical devices and active implantable medical devices. The most significant changes in the proposed regulation include:

PRODUCT SCOPE EXPANSION:
The definition of medical devices and active implantable medical devices covered under the MDR will be significantly expanded to include devices that may not have a medical intended purpose, such as colored contact lenses and cosmetic implant devices and materials. Also expected to be included in the scope of the regulation are devices designed for the purpose of “prediction” of a disease or other health condition.

NEW DEFINITIONS – PLACING ON THE MARKET IS NOW EXPRESSLY COMMERCIAL:
There are hosts of new definitions including of course for medical device, custom-made device and for making available on the market. Placing a device on the market is now defined to be something that takes place as part of a commercial activity (whether for charge or for free).  It remains to be seen whether this will provide a loophole for organizations such as charities. The definition of serious adverse event is expanded to specifically include hospitalization, medical or surgical interventions to prevent life threatening injury or illness, chronic disease, foetal distress, foetal death or a congenital physical or mental impairment or birth defect, Nanomaterials are also explicitly defined in terms or particle sizes and proportions of agglomerates, as well as Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm deemed to be Nanomaterials.

RECLASSIFICATION OF DEVICES ACCORDING TO RISK, CONTACT DURATION AND INVASIVENESS:
As expected, there is a lot of tweaking of the classification rules in the light of experience. Active Implants are pragmatically merged with an expanded Class III, which includes a range of other devices including surgical meshes, Spinal implants (except screws and plates), IVF Media and media for transplant organs or tissues. All active implants and their controllers or monitors, All devices in direct contact with the heart or central circulatory system regardless of duration Nanomaterials with high potential for internal exposure (others are IIb/IIa) Active devices with significant patient management function (e.g. Automatic External Defibrillator). Wound dressing rules now make explicit reference to devices, which come into contact with skin (or) mucous membrane. There’s also a new special subclass of ClassI. The familiar measuring function and sterile Class I(m) and I(s) remain. But now reusable surgical instruments are required to be assessed by a Notified Body specifically in relation to their cleaning and sterilization.

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