EU MDR Readiness Checklist
How to prepare and prioritise actions for MDR
A checklist normally assists in efficient planning. However, the EU MDR contains a lot of new requirements. A checklist should be a practical tool that ensures you are compliant with the regulations.
In this white paper, we present methods based on actual consulting experience to help give you the edge.
1. Assess your situation and formulate a project plan
The MDR deadlines have been delayed, but this is subject to certain conditions under Article 120. Manufacturers will need to ensure that they are eligible to benefit from the extended transition period, and ensure that their legacy products meet the new requirements to stay on the market. It is now mandatory to show you have a MDR transition plan in play, even for legacy products that will be discontinued (Article 120 requirements).
Your gap assessment checklist (GSPR or Article 120) is key requirement to show your readiness and what gaps need project planning. This will make it much clearer for the NB reviewing and easier to coordinate your MDR transition from gap assessments to strategy to technical documentation. Manufacturers frequently underestimate the resource requirements of a MDR transition and outlining it in this way is hugely beneficial.
2. Review your Quality Management System
One of the key components of the MDR is that complete compliance with ISO 13485:2016. The best place to start is by conducting a quick internal review of your QMS using a checklist. We should review the key elements, such as Management Controls, Design and Development, Corrective and Preventative Actions (CAPA), Production and Process Controls, Sterilisation Process (if applicable) Purchasing Controls, Documentation and Records, Customer Requirements, and Technical File information.
We should also note that Clinical Evaluation is now a continuous procedure during both the design phase and post market surveillance. Manufacturers should consider streamlining their business operations to ensure a smooth clinical-driven medical device life cycle.
3. Review your alignment with Technical Document structure in Annex II and III
One of the big changes for EU MDR is that the Technical Document structure is specified in Annex II and III, hence it is a conformance requirement. Previously, the Global Harmonization Task Force (GHTF) created ‘Summary Technical Documentation’ (STED) as a recommended structure to allow the NB to fulfil its obligations. Under MDD the STED was often used but could not be enforced leading to variations across manufacturers MDD Technical File structures.
As the Technical Document (TD) structure is part of the regulations in Annex II and III, Notified Bodies can enforce alignment to this structure. Meaning an NB can add qualifying sampling stage to see if TD meets Annex II and III before giving you a MDR submission date. With the pending extension of the MDR deadline, legacy products have come into focus as you need to show you have started your MDR transition plan (this includes taking the product off the market) and contract with your NB to qualify for an extension of your MDD certificate under Article 120.
4. Consider the needed validation and standards you’ll use
The MDR requires that manufacturers use common and harmonized standards which are the latest version. Technical recommendations from standardisation adds credibility of your QMS system and Design process through alignment to validated industry methodologies. It’s not uncommon for standardisation to be misunderstood and be thought as only an expensive third party testing. But a number of standards are guidance documents and methodologies (think Risk Management ISO 14971:2019). However, a lot of standards are easy to implement with an SOP update of your QMS and TD section update.
Some tests do require external tests houses such as Electrical safety and Biocompatibility. As they are costly and take a long time to execute it’s imperative to work this into your Validation Master Plan (VMP). The Validation engineering team needs to consider product life cycle, when is an update of the standard due and MDR transition timeline. The VMP timelines and GSPR requirements requires significant regulatory input to ensure its aligned and can be executed on time.
5. Evaluate product compliance
Manufacturers need to understand the new General Safety and Performance Requirements (GSPR). These replace the MDD Essential Requirements. It’s definitely worthwhile taking the time to convert your current Essential Requirements into GSPRs. A side by side checklist is easiest for this process. This enables you to highlight key deficiencies and findings between the MDD and MDR on a product compliance analysis basis. The GSPRs, in conjunction with the applicable Common Specifications and Harmonized Standards, will impose new device requirements and specifications.
As part of the design and development inputs, outputs, verification, and validation phases, we must address these changes. Compiling data for CE mark submission will no longer be sufficient. Below are just a few of the significantly updated requirements in Annex I of the MDR.
- GSPR 10.4 (Hazardous substances: CMR: carcinogenic, mutagenic, or toxic to reproduction, endocrine disrupting substances)
- GSPR 12 (Devices incorporating a substance considered a medicinal product and devices composed of substances or combinations of substances absorbed by or locally dispersed in the human body), GSPR 17 (Electronic Programable Systems)
- GSPR 22 (Devices intended for use by lay persons)
- GSPR 23 (Label and Instructions For Use)
6. Formulate an action plan
Consider using a second overall checklist for company compliance with key elements such as:
- Align your Technical Document structure to Annex II and III
- Align the quality plan to establish MDR CAPAs and Article 120 for legacy devices.
- Update QMS.
- Ensure the PRRC is aligned with new regulatory responsibilities.
- Determine your device reclassification nee and technical gap.
- Request quotes from Notified Bodies for reclassified devices.
- Establish test protocols with third party labs and request quotes.
- Update regulatory planning protocols.
- Ensure compliant PMS is in place.
- Ensure PMCF is effective and supports GDPR.
- Revise audit plan. Including distributor and essential supplier audits.
Translate this to a Project Plan ensuring:
- We translate gaps to deliverable items.
- Add timelines to milestones ensuring you outline the critical path and dependencies between deliverables.
- Identify who needs to be involved and their role as per the RACI outline (Responsible, Accountable, Support, Consulted and Informed) to ensure all key stakeholders are supportive to progress the project.
- Calculate a budget to ensure the project is adequately resourced. This is key cause of delays and costly mistakes in MDR transitions.
- Top management signs project plan off, as it is a company wide update of the QMS system. This should also assist in interdepartmental buy-in and support.
CLIN-r+ Recommendations
- Perform a gap assessment. If you’re unsure where to start with this, or just simply don’t have the capacity then consider partnering with a consultancy to support you. They can go through a checklist with you and also help create all the materials your project team needs.
- Streamline your QMS system. Make sure it meets ISO 13485 standards. It needs to be comprehensive and a good QMS will help you to identify key risks. This means that we can correctly manage them for the EU MDR.
- Look at the current medical product standard and consider if you can increase your internal testing capabilities.
- MDD to MDR transition can be difficult and time consuming to navigate. Ensure you have a project plan and enough resource allocation. Bring in advice or help early.
- Perform a thorough literature search. Any medical device must have adequate clinical evidence to demonstrate compliance with relevant, essential safety and performance requirements. A thorough and systematic Literature Search is one of the most important components of a full and complete Clinical Evaluation.
CLIN-r+ can assist and support manufacturers with ensuring EU MDR readiness and compliance. We can provide professional assistance and clarify any issues. CLIN-r+ has a wealth of experience to call upon. Get in touch!
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Translating your MDD to MDR submission
