A Midlands Engine Masterclass from MasterControl & UL

04 January 2017

New European Medical Device Regulations: How it will impact ALL medical device manufacturers

When: 7th February 2017 – 9.30am – 12pm
Where: Hinckley Island Hotel and Conference Venue, Hinckley, LE10 3JA

Medilink East Midlands and West Midlands, together with MasterControl, a global provider of quality management software solutions and services and their partner UL LLC, a global independent health sciences company, are pleased to offer a Midlands Engine Masterclass which will focus on the proposed changes to the Medical Device Regulation for the European Market due to come into effect in late 2019 or early 2020, detailing how they will impact ALL medical device manufacturers.

The masterclass will give delegates the opportunity to hear MasterControl & UL discuss the requirements within the Regulation, particularly concentrating on the CE Mark transition periods, the heightened post market surveillance and vigilance activities expected, and how notified bodies will be required to act going forward. This will undoubtedly have an impact on the number of notified bodies left to cover the needs, and costs will invariably rise.

MasterControl & UL will also examine the new products brought within scope of the Regulation that have previously not had a medical purpose, and how this might impact manufacturers not previously under the MDR requirements.

Some key points from the new MDR:
• All device manufacturers selling in to Europe will be required to establish risk management and quality management systems. 
• Changes to clinical evidence requirements and major labelling changes (Unique Device Identification (UDI) codes must be included in all medical device labels) will come into effect.
• Tighter control over distribution chains (requirements for importers, distributors and authorized representatives) and authorised representatives’ liability will increase.
• New products brought within the scope of the Regulation will have to comply with MDR requirements.
• Changes in the role of Notified Bodies and implications for CE Marking.

Member cost: Free
Non-Member cost: £50 + VAT

► Book your place: to reserve your place please visit Eventbrite


Agenda:

9.30 am – 10.00 am Registration & Breakfast Rolls
10.00 am – 10.10 am Welcome and Masterclass Introduction
10.10 am – 11.50 am New European Medical Device Regulations: How it will impact ALL medical device manufacturers – delivered by Linda Chatwin, Esq, RAC of UL
11.50 am – 12 Noon  Summary and event close


MasterControl provides a full line of industry-specific quality and compliance software solutions and services to hundreds of satisfied customers worldwide. Their offerings enable regulated companies to accelerate compliance and get to market faster while reducing costs and improving efficiency.

► Download MasterControl Medical Device Solutions
► Download MasterControl Spark - SME QMS Solutions

UL is a global independent health sciences company providing comprehensive life cycle services to support the medical and laboratory industries in achieving global regulatory approvals.  UL provides testing services and solutions, helps customers prevent and resolve complicated quality issues that could lead to recalls and liability.

Speaker:  LINDA M CHATWIN, Esq, RAC of UL

Ms. Chatwin has been involved with regulated medical products for over 30 years. She understands the global regulatory maze required to bring products to market, through years of watching regulations evolve and change. She holds a Regulatory Affairs Certification and is an attorney in the U.S.  She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. She has navigated many FDA inspections, and has negotiated favourable outcomes with FDA. Currently, she assists clients with regulatory issues and challenges, including implementation of UDI processes, performing mock audits, in-depth training on regulatory requirements and consulting on quality system development and improvement. She has also had involvement with other team members with respect to interoperability and cybersecurity issues. 

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