European Medical Device Regulation
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace. The EU MDR faq will help you out with some queries and doubts about the regulation.
EU MDR faq as follows:
Why did the MDD need an update?
There were many reasons the MDD needed to be updated. For instance, when the MDD came into law in 1992, software as a medical device (SaMD) did not yet exist. Software was something that controlled electric machines, and there were no apps that patients could use to monitor their own health. Demographics have also changed in Europe since 1992, with the population growing older, and there is a growing push for transparency of medical device technical information to the general public.
How is the new MDR structured?
The new MDR document is 174 pages in length. It contains a 13-page introduction, followed by 123 articles in 10 chapters (79 pages), and 17 annexes (80 pages). Compared with the MDD, which was 60 pages in length, the new regulations are much longer and more detailed.
What are the major thematic changes in the MDR?
Compared with its predecessor, the MDD, the new European MDR is less focused on the pre-approval stage of medical device manufacturing, and instead, promotes a life-cycle approach to medical device regulation.While the old MDD essentially served as a manual for how medical device companies could get their CE marking and get to market, the new regulations encourage policies and procedures that elevate the responsibilities of medical device companies for their products throughout the product lifecycle.
What Medical Devices are covered under the MDR?
The MDR defines the term “medical device” as an “instrument, apparatus, appliance, software, implant, reagent, material, or other article” that is used for any of the following:
Diagnosis, prevention, monitoring, treatment or alleviation of disease, disability, or injury, but not for disability or injury prevention. Investigation, replacement, or modification of an anatomical, physiological, or pathological process. Providing data via in-vitro examination of samples derived from a human body
Will the MDR require enhanced device traceability?
Yes, it will. The new MDR includes a mandate for Unique Device Identification (UDI) that is intended to facilitate the traceability of all medical devices sold in the region. Devices must be marked with a device identifier (DI) and each batch or production series of the product will be marked with a production identifier (PI).
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Phone no - 93702 83428
Mail id – enquiry@operonstrategist.com
If You Want Medical Devices Services Consultation For Following.- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
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- TURNKEY PROJECT CONSULTANT
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- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
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