Make your transition from MDD to MDR – White Paper
With less than one year remaining for the transition to the Medical Device Regulation (MDR), this white paper takes a look at the key areas to be addressed for manufacturers selling medical devices into Europe.
Update Quality Management System (QMS)
Given the new MDR requirements will impact on the existing process and procedures in the quality system on various aspects, allocating adequate resources to align QMS with the new MDR regulations while assessing and implementing changes to comply with ISO 13485:2016 will facilitate a smoother and timely transition from the MDD to MDR.
Under the new MDR requirements, the following procedures are likely to be affected:
- Premarket regulatory procedures, e.g., classification rules, regulatory pathways, general safety and performance requirements/templates, requirements for local representatives
- Procedures for planning, preparation and submission of the technical files and device entry to the European databank on medical devices (Eudamed)
- Clinical evidence
- Risk management procedures, e.g., Risk Management Plan
- Post-market regulatory procedures: e.g., post-market surveillance (PMS) plans and reports, periodic safety update reports (PSUR) and summary of safety & clinical performance (SSCP)
It is also key to be aware that the PMS activities, one of the major focus of the MDR, impose probably the most significant impacts on relevant QMS records, including CER, Risk, IFU and labelling. Hence the interconnection between all QMS processes must be reviewed across business departments to ensure consistency between QMS records and post-market data collected as required by the new regulations. If implemented properly, the new regulatory environment will provide companies with the opportunity to move beyond compliance to quality and enhance product values through improved patient safety, performance outcomes and customer satisfaction.
Review product classification and conformity assessment route
All manufacturers should assess whether the new classification rules impact on their devices on the market. For up-classified products, additional resources will be required to fill in the gap as there will be changes in conformity assessment procedures and more frequent reviews by NB. Products that may need to be recertified in a different- often higher- risk class include:
- Devices incorporating nanotechnology
- Orthopaedic implants such as spinal disk replacements or implants that come into contact with the spinal column
- Re-suable surgical instruments
- Life-saving active therapeutic devices such as closed-loop systems and automated external defibrillators
- Software (standalone software will no longer be classified as an active medical device)
Other changes in the “definition” chapter also impact on the conformity route:
- “Accessories” cover products specifically or directly assist another device in its intended purpose
- Custom-made devices exclude products that are mass-produced by means of industrial manufacturing processes
- Inclusion of products on based human cell or tissue derivatives
The new regulatory regime also mandates a risk profile similar to medical devices for products without an intended medical purpose such as cosmetic implants, contact lenses and cosmetic laser products (Annex XV). Also new to the MDR is the inclusion of the Common Specifications (CS). These are drawn up for cases where no sufficient harmonized standards are available. Manufacturers of the products captured in Annex XV can adopt the design requirements in the CS to prepare their technical documentation.
Re-evaluate clinical evidence
The MDR brings forth new requirements to clinical evaluation and clinical investigation, including a mandatory post-market clinical follow-up (PMCF) to collect quality, performance and safety data throughout the product life cycle. As compliance with the current MDD on clinical evidence is unlikely to meet the requirements under the new rules, manufacturers should perform a gap analysis to determine the impact of the new clinical investigation requirements on the existing clinical investigation for new devices but also conduct a thorough assessment to identify gaps in clinical evidence compiled for approved products.
The PMCF data is required for high risk devices where long-term safety and performance data is unknow or where EC certification is based on equivalence. For devices where long-term outcomes are available, manufacturers can provide justification without a PMCF. A summary clinical evaluation is also required to be validated by the NB and published by the European databank on medical devices (Eudamed) for Class III and implantable devices.
In cases where a clinical evaluation has been performed based on equivalency data, manufacturers need to ensure accessibility to equivalency data of other manufacturers by establishing an agreement with other manufacturers. If the equivalence data is unlikely to be accepted in the future, conducting own clinical trials should be considered.
Notified Body (NB)
Manufacturers must assess the potential of their existing NB as they may not be re-notified or may not be able to support the same scope of products anymore. It is crucial to discuss with the current NB and understand if they can meet the new requirements in a timely manner. If the re-notarization process is likely to cause long delays, alternative plans and transition procedures should be put in place for changing to a new NB.
Revisit post-market surveillance (PMS) procedures
All manufacturers will require to comply with PMS requirements in the MDR after May 26th 2020 regardless of whether an EC certification for a medical device is issued under the MDD or MDR. PMS system consists of PMS procedures that control the PMS activities, plan, report and PSUP. PMS activities should cover market feedback, customer feedback and complaints, vigilance, recalls, and collection of new data from literature or databases. As PMS activities have a major impact on various QMS records, it is crucial to ensure consistency and regular updates between different records. For example, PMS data must feed into the CER, and similarly, risk analysis must be in line with adverse events/rate collected in the PMS data and CER. Manufacturers for implantable and Class III devices are also required to submit the SSCP which includes information on therapeutic alternatives, CER summary and the list of residual risks or undesirable side-effects to the Notified Body. The MDR requirements, device class, and frequency of updates are summarised in the following table:
Identify roles and responsibilities
The MDR adds responsibilities and obligations to all economic operators in the supply chain, including manufacturers, importers and distributors, and therefore it is important that each role understands and fulfils the new requirements. Additional responsibilities for importers and distributors include:
- Verify CE mark, EC Declaration Conformity and labelling requirements (importers also need to keep the relevant declaration of certificates and conformity statements)
- Place only confirming devices on the market (importers also need to check the registration of device and add its own details in the Eudamed)
- Comply with storage and transport conditions set out by manufacturer (importers also need to check compliance with Annex I)
- Inform competent authorities (CA), NB and operators upstream in the supply chain on serious risks, keep records of complaints, non-conforming devices, recalls and withdrawals
- Inform operators upstream in the supply chain on potential non-conformities and complaints
- Co-operate in corrective actions and provide samples or access to CA
- Ensure traceability on economic operators, health institutions, healthcare professionals supplied with the devices via means of establishing/updating documents such as contracts, written nominations, databases entries as mandated by the MDR
- Distributors also need to register their information in the national database
Manufacturers need to implement below changes to fulfil additional obligations:
- Check and update all contractual arrangements with the partners in the supply chain to ensure alignment with the MDR requirements, e.g., clarify liability conditions for local representatives, update SOPs for the implementation of Unique Device Identifiers (UDIs)
With the uncertainty of the current Brexit deal, it is recommended that manufacturers choose their NBs and RAs outside the UK to avoid roadblocks down the road.
Changes brought about by the regulation are significant and require manufacturers to take proactive and multilevel decisions on implementation. MDR impacts all areas of the business, including supply chain arrangements, regulatory resources and processes and marketing. Understanding the EU MDR requirements and identifying its impact on the business is critical to a successful transition. Manufacturers will likely need to assess their product portfolio and readiness in the context of the new regulation to prioritize their transition effort.
How robust is your transition plan to the new MDR? Our team of consultants have extended experience with navigating through regulatory changes and can customize a plan for your specific needs. Please do not hesitate to contact us for an obligation free conversation.
If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)