Common Pitfalls in Manufacturer Technical Documentation Submissions to Notified Bodies; Ways to Overcome These.

In the recent publication of MDCG 2022-14 responding to a Team NB initiative, best practice guidelines have been prepared by over 20 notified bodies, for manufacturers to assist them in the MDR application phase, including information about the preparation and content of technical documentation. This workshop will discuss the common pitfalls in manufacturer technical documentation submissions to notified bodies. The session will discuss how notified bodies are correcting this by providing common guidelines to increase the preparedness of manufacturers, especially SMEs and first-time MDR applicants, to adapt to the high-level standards set up by the MDR. The workshop will include the collaborative notified body approach on technical documentation submission and leveraging of evidence from past Directive assessments.

The session organizers have requested that you bring your laptop with you to the workshop.

Also, below are some materials that will be referenced during the preconference workshop. You may want to save a copy to your laptop.
MDR (EU) 2017/745
MDCG 2021-24
e-IFU Regulation EU 2021-2226
Device Description activity PDF
GSPR activity PDF
Risk Management activity PDF
Product V&V activity

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Workshop Agenda (Subject to Change)

7:00-8:30 am
All Workshop Registrants: Registration, Continental Breakfast & Welcome

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8:30 - 9:00 am
Welcome to the workshop

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9:00 - 10:30 am
Case Study on MDR Annex II Technical Documentation – common pitfalls identified such as design & manufacturing information, selection of applicable GSPRs and pre-clinical data.

How to ensure the requirements of Annex II are documented effectively within the Manufacturer’s Technical Documentation.

Presenters:
Purvi Patel (BSI)
Vishal Thakker (BSI)

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10:30 - 11:00 am
All Workshop Registrants: Refreshment Break

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10:45 - 11:05
MDR Annex II Technical Documentation – common pitfalls wrap-up.

Presenters:
Purvi Patel (BSI)
Vishal Thakker (BSI)

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11:05 am - 12:30 pm
MDR Clinical:
a. CEP (CLINICAL EVALUATION PLAN)
Overview of the CEP in relation to Annex XIV Part A and common pitfalls identified such as identifying meaningful and measurable objectives.

b. CER (Clinical Evaluation Report)
Overview of expected contents of the CER with a focus on presentation of data including stratification and how to avoid questions from the notified body on gaps in the data.

c. SSCP (Summary of Safety and Clinical Performance)
Discussion around template and common issues associated with submissions, grouping solutions.

Presenters:
Rachel Mead (BSI)
Alexey Shiryaev (DNV)

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12:30 - 1:30 pm
All Workshop Registrants: Lunch

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1:30 - 1:55 pm
MDR Clinical – common pitfalls wrap-up

Presenters:
Rachel Mead (BSI)
Alexey Shiryaev (DNV)

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1:55 - 3:45 pm

MDR Post-Market Surveillance (PMS):
a. PMS Plans.
How to ensure requirements of Annex III are documented effectively within the PMS Plan.

b. PMS/PSUR Reports.
How to document the output of PMS plans into the appropriate reports based on classification. (Class I – PMS Report/Class IIa, IIb, and Class III PSUR).

c. PMCF (Post Market Clinical Follow) Plans.
How the PMCF Plan differs from a PMS report and how this all fits in within the PMS plan.

d. PMCF Reports.
Documenting General and specific PMCF activities within your PMCF report and the impact to this data in other regulatory documents.

Presenters:
Rachel Mead (BSI)
Alexey Shiryaev (DNV)

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3:45 - 4:00 pm
Overall wrap-up & adjournment

Presenters:
Purvi Patel (BSI)
Vishal Thakker (BSI)

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