1. Quality and Regulatory Planning – the way forward?
Dr Simon Richards
MEDDEV QA Ltd

2. EN ISO 13485: 2012 Top management shall ensure that
Clause Quality Management System Planning
Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements, as well as the quality objectives, and
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 

3. EN ISO 13485: 2012 Clause 5.6 - Management Review 5.6.1 General
Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. 
5.6.2 Review Input
The input to management review shall include information on new or revised regulatory requirements 

4. NEW OR REVISED REGULATORY REQUIREMENTS
EN ISO 13485: 2016 – published in March (with a three year transition period)

5. NEW OR REVISED REGULATORY REQUIREMENTS
Medical Device Single Audit Program (MDSAP) - to be implemented by 1st January 2019
Medical Device Regulations - Regulation (EU) 2017/745 – published on 5th April 2017 (with a transition period to 25th May 2020)
In Vitro Diagnostic Device Regulations (EU) 2017/ published on 5th April 2017 (with a transition period to 25th May 2022)

6. QUALITY AND REGULATORY PLANNING – MEDICAL DEVICE REGULATIONS
Notified Body
Technical Documentation - General Safety and Performance Requirements
Classification Changes
Conformity Assessment Changes – More Pre-Market Authorisation leading to less predictability for review and approval timelines
Unique Device Identification (UDI)
Clinical Evaluations – with a greater need for Clinical Data
Periodic Safety Update Reports (PSUR)
Person Responsible for Regulatory Compliance
Role of the Authorised Representative and Economic Operators
Role of the EUDAMED Database

7. QUALITY AND REGULATORY PLANNING - IVD DEVICE REGULATIONS
Under the current IVD Directive % of IVDs require Notified Body intervention
Under the IVDDR 85 – 90% of IVDs will require require Notified Body intervention

8. QUALITY AND REGULATORY PLANNING- MEDICAL DEVICE AND IVD REGULATIONS
Notified Body scrutiny of manufacturers will increase
Notified Bodies will be required to have more technical and clinical expertise
BUT Notified Body resources (and resource in general) will be limited
Choose you Notified Body wisely and confirm their competency and available resources
You may have to change Notified Body

9. BUT DO PLAN!