Introduction to the course
This MTSA (Medical Technologies Skills Academy) course is aimed at both Medical Device and in vitro Diagnostic companies operating within the EU and CE Mark dependant territories, where the new Medical Device Regulation 2017/745 (MDR) and/or the new in vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) is recognised. It is also applicable to any company offering EUAR services (EU Authorised Representative).
For Medical Devices the ‘Date of Application’ was 26 May 2021, meaning that all the provisions of the new regulation became applicable, even if manufacturers are taking advantage of the extended transition period. These new provisions include, amongst others, the new Vigilance reporting timelines, all Post Market activities and the requirement to have a Person Responsible for Regulatory Compliance (PRRC).
Study mode: Part-time/ Distance
Course fees: £1,800
Course duration: 50 hours; 12 hours of interactive training with additional follow up work and assessment
Course dates: 24 and 25 January 2022
What you'll learn
This training course is a two-day, online, interactive course and covers all the requirements of Article 15 of the MDR and Article 15 of the IVDR. This course is equivalent to a 5 credit module, comprising approximately 50 hours of work, including:
- Two-day training course (12 hours in total)
- Guided reading and follow up work (30 hours)
- 1-2-1 follow up with a course tutor
- Training assessment
- Brief introduction to the MDR and IVDR
- A short background to the regulation of medical devices and IVDs in the EU and how the ‘new’ regulations came about. What the main differences are between the old Directives and the new Regulations.
- Article 15 (MDR)
- Article 15 defines the requirements for Person Responsible for Regulatory Compliance (PRRC). We will go through all of the requirements detailed in Article 15, as a prelude to a more detailed understanding of the requirements, line by line later in the course.
- Article 15 (IVDR) – differences
- Article 15 exists in both the Medical Device ‘MDR’ and the Diagnostics ‘IVDR’. The requirements are highly similar, but there are some differences to point out.
- Important Definitions & Understanding the Vernacular
- The language used in the Regulations is not always helpful to the novice or inexperienced person. We will go through important definitions to help provide a full understanding of the requirements and provide an explanation of the language and terms used in the regulations.
- Personal liabilities
- The PRRC is an important and responsible position that is specifically required in the regulation. The role is often fulfilled by a named individual but can be shared by more than one person. This section explains where the liabilities lie for the responsibilities of the PRRC.
- Qualification of personnel for PRRC Vs ability to fulfil the role
- Article 15 details exactly what qualifications and experience are required for the person fulfilling the role of PRRC. There is more than one route available, yet neither route guarantees an individual’s ability to be able to carry out the role with competence. One of the main reasons for people to learn more on this course.
- Understanding the requirements, line by line
- A detailed line by line analysis of all of the requirements for the PRRC, what they mean and practical approaches in meeting the requirements.
- Day 1 Review
- A brief recap of the main points from Day 1.
- Understanding the requirements, line by line (continued)
- A continuation of the detailed line by line analysis of all of the requirements for the PRRC, what they mean and practical approaches in meeting the requirements that began during Day 1.
- Practical Approaches
- The practical approaches are integrated into the detailed line by line analysis.
- MDCG (Medical Device Coordination Group) guidance document
- The MDCG is an important advisory body to the European Commission. The MDCG has produced a large number of important guidance documents assisting in the understanding of the requirements of the MDR and IVDR. Here, we go through the MDCG guidance document for the PRRC.
- A Notified Body Perspective
- BSI, one of the leading Notified Bodies in the EU has produced a White Paper on PRRC. Given that Notified Bodies have the responsibility and authority to review each manufacturer’s compliance to Article 15, it is important to understand how the regulators see the issues. BSI’s whitepaper provides an overview of the requirements together with the practical considerations to be made, from a Notified Body perspective.
- Team PRRC
- Team PRRC describes itself as a “non-profit European Association dedicated to the new profession of ‘Person responsible for regulatory compliance’ (PRRC)”. The Association is a significant resource for information with further resources available to members. A brief introduction to Team PRRC is given.
- Reading List
- A reading list for further self-directed is provided.
100% portfolio assessment:
- Sub-element 1: Short essay answers to questions
- Sub-element 2: Assessment of involvement
How to apply
Please visit our online store to book your place on the course.
Course leader: Peter Rose BSc (Hons), CBiol, MSB, PCQI, MTOPRA
Additional tutors: Philip Breedon BSc (Hons), PhD and Mike Hannay BSc (Hons), PgD, MSc, MBA, DSc
Peter is the founder and principal consultant of PRQR Ltd. With 19 years’ experience in consulting and 28 years of experience working in the field of Medical Devices and In Vitro Diagnostics, Peter has expertise covering Quality Assurance, Regulatory Affairs, Sterilisation, Cleanrooms and Contamination Control.
He is a qualified Microbiologist, a Chartered Biologist, Member of the Royal Society of Biology, Practitioner Member of the Chartered Quality Institute and a Member of TOPRA. Peter has an abundance of experience and expertise in Quality, Regulatory and microbiological matters for Medical Devices and IVDs across the UK and Europe.
Peter possesses a range of technical and business skills that enable him to provide unique insight to new and emerging businesses. He takes a hands-on approach to challenges and is adept at creative problem-solving. Peter has extensive senior leadership and board-level experience. As a well-regarded voice within the industry, In addition to being a director for Medilink, Peter sits on a variety of industry committees and working groups and has been invited to address the European Parliament and UK Government ministers.
Peter’s extensive experience includes the new Medical Device Regulation, the new IVD Regulation the three established Medical Device Directives. He also has expertise in quality management systems covering ISO 9001, ISO 13485 and 21 CFR 820 (QSR).
Mike is a strategically focused, board executive with a successful, international track record of driving growth through innovation. He has extensive experience in medicines and medical technology development having led Discovery, CMC, Clinical, Regulatory and Commercial teams to bring innovative new medicines and devices to millions of patients around the world.
Mike has a proven ability to develop clear strategies that deliver profitable growth through customer engagement, employee empowerment and product innovation.
He is driven by the spread of innovation in the NHS improving patient outcomes, driving down the cost of care and stimulating economic growth and now leads the Medical Technologies Innovation Facility (MTIF) to accelerate the development of innovative medical technologies from bench to bedside.
MTIF enables innovative medical technologies to progress from "bench to bedside". Our mission is to improve the quality of patient care by helping organisations accelerate the development and commercialisation of innovative medical technologies and devices. Based at Nottingham Trent University and Boots Enterprise Zone they work in partnership with academia, NHS Trusts, MediLink East Midlands, EMAHSN, D2N2 LEP, CHEATA and BioCity to provide a unique ecosystem for medical technology innovation.
As part of the course, the module content will cover Team PRRC:
Team PRRC is the non-profit European Association dedicated to the new profession of Person Responsible for Regulatory Compliance (PRRC), which originated in Article 15 of the Regulation (EU) 2017/745 (MDR) and in Article 15 of the Regulation (EU) 2017/746 (IVDR) of the European Parliament and the Medical Device Council.
The Association was created to help PRRCs to more confidently assume this new profession which has considerable responsibilities in the design, manufacture and supply of medical devices and in vitro diagnostic devices.
Through the networking it allows, along with the framework it provides and the rigour of its analysis of requirements and guidance available; the Team PRRC Association aims to promote greater security for the PRRC professional themselves, as well as for patients and health authorities.
Get in touch
If you have any further questions regarding the course or how to apply, please email us at firstname.lastname@example.org.