EU Medical Device Regulation and Clinical Evaluation Report Development

To go from a classified product to having the product available for purchase requires several steps, one of which includes regulatory approval. The EU, like any other geographical market, has its own set of regulatory requirements. These regulations are undergoing significant changes for which you need to be prepared!

Need a CE mark for your product? You will need to address the following:

  • Define and update your internal regulatory, clinical, and quality system processes to address the legal changes to the EU Medical Device and In-Vitro Diagnostic regulations
  • Harmonize and Integrate the updated processes with regulatory requirements from other markets in your distribution chain
  • Identify those products you want to continue distributing in the EU and update their respective Technical Files (TRs), including the Clinical Evaluation Reports (CERs)
  • Manage or support your ongoing Notified Body communication to meet business and regulatory timelines

RQMIS has authored numerous Technical Files meeting the requirements of the Medical Device Regulation (MDR). A critical part of the Technical File is the Clinical Evaluation Report. We have successfully created CERs per MEDEV Guidance 2.7/1 Rev 4.

RQMIS understands that ~85% of the MDR requirements are covered in the MDD. However, even where the requirements are consistent, the MDR is more prescriptive in what evidence is expected to demonstrate compliance. For example, are residual risks identified in your product risk profile represented in product labeling?

RQMIS provides expert guidance that will ensure your products comply with the MDR and the MEDEV guidance on CERs. RQMIS consultants and medical/technical writers can create or edit your TFs and CERs to assure CE marking success. Our Regulatory/Quality Consultants can establish, update, and implement quality system processes that will assure you apply these new requirements in a consistent and effective manner. RQMIS can also provide annual updates to these files.

Already selling Product in the EU?

A new MDR has replaced the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). All submissions in the EU must conform to the new MDR on 26 May 2020.

What This Means

The new MDR changes the market access landscape for all member countries of the European Union, and it aims to ensure a higher level of protection for patients and users. Some key changes associated with the MDR include:

  • Clinical Data - companies will need to generate and provide more in-depth clinical data to prove safety and performance claims, including tighter equivalency standards
  • Global Products - companies will need to rationalize their global product portfolios and perform a global impact assessment in order to implement the necessary changes to remain compliant

RQMIS can evaluate your current compliance to the MDR and determine any impacts to your Quality Management System (QMS) and product lines. In addition, RQMIS provides:

  1. Training - RQMIS ensures your company has a thorough understanding of the new legislation and the changes from the current Medical Devices Directive
  2. Analysis - RQMIS conducts thorough gap assessments to review your current products against the new legislation. The gap assessments consider the reclassification of certain product groups as well as MDR’s wider definition of a medical device
  3. Product line assessment - RQMIS assesses your portfolio (impacted products) and determines the impacted products and legacy products
  4. Action Plans and Surveillance - RQMIS develops your Company’s action plan for the transition (including vendors), and defines the work needed with the Notified Bodies. RQMIS will then check effectiveness and monitor ongoing systems and processes
  5. Ongoing action - RQMIS will help with annual and long term updates required with the new MDR
  6. Consultation - RQMIS will always be available to support your MDR needs in your first years of the transition

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