CE Mark Consulting Services

Introduction

The CE Mark on a product indicates that it complies with all the applicable requirements of the European Union. Obtaining the CE Mark allows your company to freely commercialize the product in the European Economic Area (EEA).

To obtain CE mark for Medical devices, manufactures are now need to comply with the new Medical Device Regulations (MDR) 2017/745. Manufacturer need to demonstrates compliance with general safety and performance requirements Annex I of MDR 2017/745. With the commencement of MDR, requirements have become more stringent.

MDR 2017 / 745 is new regulation for medical devices in Europe.
On April 5, 2017, the EU adopted the new Medical Device Regulation, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD).
This means that MDR is required to access the European market (EU member states, the members of the EEA – Iceland, Lichtenstein and Norway, and through bilateral treaties Switzerland)
NO Grandfather Status – Existing devices will NOT be automatically grandfathered into the new Regulation without complying with the new MDR requirements. Means, NO CE Certificate transfer from MDD to MDR.

Regulation vs Directive
175 pages document vs 60 MDD
123 articles and 17 Annexes vs 23 articles and 12 Annexes
MDD and AIMDD integrated into MDR
MEDDEV guidelines integrated
Shift from pre approval stage to ‘life cycle approach’
More EU Control
More NB Harmonization
Active from 26 may 2020 (Will be delayed by a year due to COVID 19 Outbreak)
New MDR CE certificates has to obtaine for existing devices.

Minimum 1 unannounced audit mandatory
Reinforced conformity assessment on Notified Body (NB) and other economic operators (including manufacturer, Authorised Representative, importer, distributor)
Clearer obligations for economic operators.
More stringent requirements for documentation: Requirements are much more detailed regarding both content and regular updates of technical documentations and there is an increased focus on clinical assessments. Importantly, there will be no differentiation between class III product documentation and the other classes.
More stringent requirements for clinical evaluation.
New classification rules. (such as introduction of rules for medical devices with non medical purpose.)
New requirement: Appointment of PRRC (Person Responsible for Regulatory Compliance)
Notified bodies more strictly regulated
Extended scope: now includes devices with non-medical purpose
New scrutiny procedure for high risk medical devices
Enhanced market surveillance by Authorities
EUDAMED: Europe-wide database for more transparency and cooperation
Greater emphasis on supply chain traceability.
UDI: unique device identification number for every medical device.
PMCF is mandatory for all devices. Annual reporting of PMCF Report is mandatory.
PMS is proactive.
IFU, label and summary of safety and performance (criteria for CE approval) will be made public.
Damage compensation – pre requirement for Clinical investigation.
Italian Medical Device Codes (CND) will replace GMDN in Europe.
Under MDR, class III implants and active class IIb products which are intended to administer and/or remove medicinal products from the body are subject to a double safety mechanism. First, these products must undergo clinical consultation with expert panel before they are placed on the market. Once on the market, they might be put through a scrutiny process.

We have the experiences and expertise preparing technical file and can work with any Notified Body of your choice. We can assist you to switch smoothly from MDD to MDR by auditing the gaps in the existing documents or creating new documents.

Medical Device Technical File should be prepared as per MDR 2017 / 745 Annex II. Technical file should be clear, well-organized, readily searchable and unambiguous manner to demonstrate the safety and performance of the device.

Irrespective of a device class, intended use, construction and or safe history of the device, the manufacturer must have and keep up-to-date technical file to demonstrates compliance with general safety and performance requirements Annex I of MDR 2017/745. Rbridge can help you with following services.

Preparation of Technical File as per MDR
Transition of existing technical files from MDD to MDR
GAP Analysis in the existing documents
Risk Management Report
1. GAP analysis in exiting Risk management report
2. Performs Risk Identification and Benefit-Risk Analysis with the support of the manufacturer
3. Sets up Risk Management documents such as Risk Management Plan (RMP), Hazard Traceability Matrix, Risk Management File (RMF), etc. with the support of the manufacturer

Clinical Evaluation Report Preparation
1. Gap analysis in existing Clinical evaluation report
2. Identifies the equivalent/similar device with same risk biological clinical and technical equivalency with the support of the manufacturer
3. Identifies patient population, clinical conditions, contraindications, warnings with the support of the manufacturer
4. Prepare Clinical Evaluation report, Post Market Surveillance Report and Periodic Safety Update Report
Device Classification
Strategies for conducting tests such as Evaluation of Safety, Biocompatibility, Physical characterization tests, Chemical characterization tests, Stability studies, Validations, Verifications, etc. with the support of the manufacturer.
Supports in biological evaluation documentation and testing
Helps in identifying the Notified Body and submitting the MDR/IVDR Application
Prepares Usability Engineering Documentation
Help manufactures to prepare PMS plan and PMS report/PSUR.

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