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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
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Strategy for regulatory compliance - MDR-compliant SOP checklist

In the context of the EU Medical Device Regulation, a strategy for regulatory compliance is a structured framework that ensures all regulatory requirements are met for placing medical devices on the market or keeping them there. Developing and maintaining a regulatory compliance strategy is an ongoing process that must adapt to evolving regulatory expectations, new device iterations, and feedback from post-market data. A comprehensive regulatory compliance strategy under the MDR typically consists of several interconnected elements that are covered by the checklist below.

Strategy for regulatory compliance - MDR-compliant SOP checklist

In the context of the EU Medical Device Regulation, a strategy for regulatory compliance is a structured framework that ensures all regulatory requirements are met for placing medical devices on the market or keeping them there. Developing and maintaining a regulatory compliance strategy is an ongoing process that must adapt to evolving regulatory expectations, new device iterations, and feedback from post-market data. A comprehensive regulatory compliance strategy under the MDR typically consists of several interconnected elements that are covered by the checklist below.

This checklist provides a suggested framework for creating an SOP for a regulatory compliance strategy. It should be tailored to address the specific needs and circumstances of your company.



Fill out the Company field, check the checkboxes for available requirements and N/A boxes for requirements that do not apply to your device and print out or create a PDF-document.

Checklist for an SOP: Strategy for regulatory compliance

Date:



# Section Covered N/A
1 DISTRIBUTION LIST
2 OBJECTIVE
3 RESPONSIBILITY FOR DEVELOPING, MAINTAINING AND IMPLEMENTING THIS PROCEDURE
4 GENERAL PROVISIONS FOR REGULATORY COMPLIANCE STRATEGY
4.1 Identification of relevant legal requirements
4.2 Identification of relevant safety and performance requirements
4.3 Responsibility for regulatory compliance
4.4 Conformity Assessment
5 DEVICE CLASSIFICATION
5.1 Classification in the EU
5.2 International classifications
6 TECHNICAL DOCUMENTATION MANAGEMENT
6.1 Compilation
6.2 Review
6.3 Approval
6.4 Document Control
6.5 Continuous Update and Maintenance
7 CLINICAL EVALUATION
8 POST-MARKET PERFORMANCE FOLLOW-UP (PMCF)
8.1 PMCF Planning
8.2 Reporting
9 RISK MANAGEMENT
9.1 Key Elements of Risk Management
10 POST-MARKET SURVEILLANCE
10.1 Algorithm for PMS Post-Market Surveillance
11 EQUIVALENCE OF DEVICES
11.1 Key Steps in Handling Dvice Equivalence
11.2 Technical Equivalence
11.3 Biological Equivalence
11.4 Clinical Equivalence
11.5 Documentation and Justification
11.6 Post-Market Surveillance of equivalence data
12 COLLABORATION WITH NOTIFIED BODIES (as applicable)
12.1 Selection of a Notified Body
12.2 Application and Agreement
12.3 Initial Review and Audit Planning
12.4 Quality Management System Audit
12.5 Technical Documentation Review
12.6 CE Certificate
12.7 Ongoing Surveillance and Audits
12.8 Recertification
12.9 Communication and Reporting
13 APPOINTMENT OF A PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)
13.1 Qualifications and Expertise
13.2 Roles and Responsibilities
13.3 Independence and Authority
13.4 Documentation of Appointment
14 EUDAMED REGISTRATION
15 TRAINING AND CONTINUOUS IMPROVEMENT
15.1 Staff Training
15.2 Internal Audits
16 COMMON SPECIFICATIONS ANALYSIS
17 HARMONIZED STANDARDS EVALUATION
18 COLLABORATION WITH REGULATORY AUTHORITIES IN NON-EU COUNTRIES
19 RECORD-KEEPING AND DOCUMENTATION
20 REVIEW AND UPDATE

Other checklists for MDR/IVDR compliance

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

MDR-compliant quality system documentation checklist for medical device software

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

Strategy for regulatory compliance - SOP checklist

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Checklists

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

All checklists >>


Useful information

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

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Send us an email:
info@mdrc-services.com

Or use the contact form below

 

Solutions

EU Authorised Representative (EC REP)

EU PRRC

Technical documentation

Risk management

Clinical evaluation

Notified Bodies

Quality management system

Post-market surveillance

Resources

Medical Device Regulation (MDR) - basics

CE-marking process for medical devices

CE-marking process for in vitro diagnostic medical devices

PRRC under MDR or IVDR

UDI infographic

EUDAMED registration step by step instruction

ISO 14155:2020 structure and content

MDR-compliant technical file

Checklists

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

All checklists >>

Articles

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

More articles >>

Devices

General medical devices and equipment

In vitro diagnostics (IVD)

Medical software

Cookie Policy

We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.