MakroCare can make sure you are fully equipped and in compliance with the new EU MDR regulations.
MakroCare’s team is expert on how the new EU MDR regulations will change current medical device processes and requirements. From structuring a clear timeline to conducting a strategic gap analysis to providing EU MDR training for continuous progress, we ensure your implementation process will meet the deadline with the specialties necessary to accurately advise the transition.
Till date, we supported over 700 products in transition from MDD to MDR in last 3 years.
EU MDR Key Changes
- Expansion of products that are covered under Medical devices and Active Implantable Medical Devices that may not have medical intended purpose
- Stricter control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
Reinforcement of the criteria for designation and processes for identification of Notified Bodies - EU MDR mandates the use of Unique Device Identification for improved transparency to enhance the ability of the manufacturers and Health Authorities to trace specific devices through the supply chain, and to facilitate the timely and efficient recall of medical devices those found to present a safety risk
- Reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorization of multi-center clinical investigations
- Strengthening of post-market surveillance requirements for manufacturers to reduce risks from unsafe devices
- Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance
Our Services & Capabilities
Regulatory Strategy
Building up an ideal Regulatory strategy depending on the device for you to effectively get a handle on EU MDR aspects including Technical, Quality, Clinical, Post-Marketing, Labeling, Economic Operators and other areas.
GAP Analysis
MakroCare reviews Tech files & data to find the gaps in EU MDR compliance and provide a remediation plan to address those gaps.
Clinical Evidence
Full service clinical evidence programs from advisory to implementation involving Retrospective/ EMR data, Surveys, Literature and setup of Registries. Review your device data, determine usability & final report generation.
Post Market Support Activities
Support PMS along with PMCF formalizing a plan for aggregate reports by process creation to standardization of templates/SOPs. Also Support in PSUR, SSCP and annual updates.
UDI Setup
MakroCare advice in setting up UDI program along with required software
Vigilance & Safety Reporting
MakroCare supports with reporting incidents, complaints and safety in the US, Europe and other markets.
Labeling
As every label needs to change, we can assist in reworking on your IFUs and corresponding artwork (labels) accordingly.
Technical Assistance
Our Technical team helps in Biocompatibility , Risk management documents, and Usability Study/Reports. We can provide custom model to fit offsite or onsite resources to work on this interactively.
Achieving your EU MDR certification requires a clear strategy, partnering with a notified body, compliance with new regulations – and a lot of documentation. That’s why MakroCare offers independent quality control checks of your EU MDR application to ensure that there are no administrative, clinical, or technical gaps that can derail your certification. And if your notified body does send you notice of non-conformities, we can help you draft a compliant response outlining the planned mitigation for each one.
Are you prepared for EU MDR?
MakroCare has to knowledge and experience, to support your EU MDR compliance journey.
