EU Medical Device Regulation
Since decades, regulation of the medical device industry in Europe has been rather unchanged. However, recent events have now prompted for vital regulatory & compliance reforms to the medical devices industry. The new Medical Device Regulation adopted by EU, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive.
To meet the new EU Medical Device Regulation objective, organizations will need to take a structured and well-managed approach over the next coming years depending on the product portfolio.
EU MDR Timeline
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:
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
MakroCare reviews Tech files & data to find the gaps in compliance and provide a remediation plan to address those
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
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
As every label needs to change, we can assist in reworking on your IFUs and corresponding artwork (labels) accordingly.
If your internal teams need short-term support in updating BERs or Risk management documents, we can provide custom model to fit offsite or onsite resources to work on this interactively.