European Commission issues further guidance for manufacturers

Fact sheets and implementation models for regulation of medical devices made available

The Medical Devices Regulation (MDR) - Regulation (EU) 2017/745 - and In Vitro Diagnostic Medical Devices Regulation (IVDR) - Regulation (EU) 2017/746 - were published in the Official Journal of the European Union on 5th May 2017. The Regulatory Framework for medical devices is described on the European Commission's website. This site provides background to the new Regulations as well as guidance on the Directives for medical devices. The site has recently been updated with five documents under the title 'Information for manufacturers'. These documents are:

1. Factsheet for manufacturers of medical devices

2. Factsheet for manufacturers of in-vitro diagnostic medical devices

3. Implementation model: medical devices

4. Implementation model: in-vitro diagnostic medical devices.

5. Exhaustive list: requirements for medical devices manufacturers

The two factsheets, one for manufacturers of medical devices and the other for manufacturers of in vitro diagnostic medical devices (IVDs), provide a general overview of the respective Regulations; a summary of the changes from the Directives for medical devices; information on what the changes mean in practice; and answers to frequently asked questions.

The two implementation models, again one for manufacturers of medical devices and the other for manufacturers of IVDs, provide step by step guides on what you need to know to implement the changes in the legislation. The twelve steps covered are:

• Pre-assessment to understand the importance and business implications, staffing capability and availability, budget implications.
• Gap analysis to assess impact on products, internal resources, organisation and budget and determine resulting actions.
• Quality Management System (QMS) analysis to understand the adequacy of QMS to meet standards and processes under the new Regulation.
• Legal entities review to clarify the obligations of all the organizations in the supply chain.
• Portfolio review to understand the cost/benefit analysis for your product portfolio and plan the transition.
• Master implementation plan preparation to build a roadmap for implementation.
• Notified Body communication to determine their capacity and availability.
• Regulatory training to build staff competence.
• Execution of master implementation plan to implement the necessary sub-projects and ensure effective cross-functional project management.
• Review of the efficiency and effectiveness of progress against plan as part of the management review process.
• Notified Body discussion on submission dates to avoid delays.
• Ongoing monitoring of the still-developing European regulatory environment and guidelines and regular review of the MDR/IVDR implementation plan/s.

The fifth document, the exhaustive list of requirements for medical device manufacturers, was produced by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). It provides a summary of the tasks that need to be completed, the element of the legislation from which that task is derived, who needs to complete the task and by when it needs to be completed.

The publication of this guidance for manufacturers is a further reminder that the time for prevarication is over and the timelines are set. You need to start implementing your transition plans. Failing to be ready in time could stop you selling your devices in the EU. There are a number of other resources available to help with transition planning, including MHRA's Introductory Guide to new medical device regulations, MedTech Europe's flowcharts of the regulations and BSI's white papers and Compliance Navigator.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development