MDR Implementation Service

The new EU Medical Device Regulation (EU MDR) was approved in March 2017 by the European Council and in April 2017 by the European Parliament. The regulation was originally to enter into force on May 26, 2020; however as of April 2020 the change has been postponed for 12 months.

The new regulations seek to increase medical device safety and effectiveness in the EU Market while addressing weaknesses revealed in the implementation of the Medical Device Directive. The MDR is also a response to technical and scientific developments that are quickly shaping the medical device industry. The regulations feature several significant changes. As part of our Medical Device Consulting Services for Pharma, Medical Device and Combination Products, Swiss MPC’s Fast-Track MDR Implementation can support your products transition to the new regulations by completing an assessment against the following key MDR changes:

·        Vigilance and Postmarket Surveillance (Articles 84, 85, 86, 87, 88, 93)

·        EUDAMED Database (Article 33)

·        Role of Economic Operators (Articles 10, 11, 13, 14, 30) and Person Responsible for Regulatory Compliance (Article 15)

·        Scope and Classification of Products (Article 1, Article 2, Article 22, Article 23, Article 51, Article 52,  Annex VIII, IX, X, XVI), Strict Rules for substance-based devices and devices that use hazardous substances (Classification Rule 21 and Annex I) and New rules for software and apps (Classification Rule 11)

·        Changes affecting Notified Bodies

·        Unique Device Identification (UDI)/ Implant Card (Article 27, Article 87, Article 18, Article 19)

·        Direct marking of UDI barcodes on devices

·        Summary of Safety and Clinical Performance (Article 32)

·        Clinical Evaluation / Postmarket Clinical Follow-up, Clinical Investigations (Article2, Article 55, Article 61, Annex XIV, Annex XV)

·        Summary of Changes in Safety and Performance Requirements (Annex I)

Benefits of using Swiss MPC 

  • Efficient Expertise - Our team has a wide range of exposure and experience accross the medical device landscape
  • Competitive fees
  • All in one team based solution
  • Excellent availability and fast project on-boarding
  • Senior Consultants as single point of contact
  • Staffing from 0.5 to 10 FTEs within 3 weeks
  • Fully remote working options available
  • Full quality control by Senior Consultants in Switzerland

Any questions? Receive an answer within 24 hours!