European Union Technical Documentation - MDR 2017/745
Van Hoven Consulting is now offering Medical Device Regulation (MDR) 2017/745 Technical File Remediation. John has conducted a large number of technical file updates to the latest MDR regulation, and is prepared to do the same for you.
Partnering with Fang Consulting, we can provide a team of regulatory and quality professionals trained on the gaps between the MDD (93/42/EEC) and upcoming MDR (2017/745), to conduct a gap analysis of your technical documentation and advise on the updates to historical data, including your clinical evaluation reports (CERs). We have a gap assessment tool and an updated General Safety and Performance Requirements checklist (previously known as the Essential Requirements Checklist) ready to apply to your products.
Ensuring all elements of a CE Technical File for a medical device or in-vitro diagnostic (IVD) are met doesn't need to be difficult. Negotiating with EU Notified Bodies can be easier when you understand their requirements and know how to meet them. Have a plan ready when you go to your Notified Body to discuss how you will meet the latest MDR - Van Hoven Consulting has a plan for you.
Van Hoven Consulting is available to help with the following:
To discuss these and other aspects of CE marking your medical product, contact Van Hoven Consulting today.
Partnering with Fang Consulting, we can provide a team of regulatory and quality professionals trained on the gaps between the MDD (93/42/EEC) and upcoming MDR (2017/745), to conduct a gap analysis of your technical documentation and advise on the updates to historical data, including your clinical evaluation reports (CERs). We have a gap assessment tool and an updated General Safety and Performance Requirements checklist (previously known as the Essential Requirements Checklist) ready to apply to your products.
Ensuring all elements of a CE Technical File for a medical device or in-vitro diagnostic (IVD) are met doesn't need to be difficult. Negotiating with EU Notified Bodies can be easier when you understand their requirements and know how to meet them. Have a plan ready when you go to your Notified Body to discuss how you will meet the latest MDR - Van Hoven Consulting has a plan for you.
Van Hoven Consulting is available to help with the following:
- Determine what changes need to be made to meet the new MDR. Do you need a complete overhaul of your technical file for historic products that haven't been touched in 30 years? Or are you preparing your first technical file for a new product and want to meet the MDR with your first CE marking audit? Van Hoven Consulting has a plan.
- Determine if your historical standard testing data reports meet the latest testing requirements set out in the new MDR? Remember, there is no grandfathering of old data without justification; notified bodies are going to be looking for evidence showing you meet the latest standards - be prepared to show them how you do that. Van Hoven Consulting has a plan. Human factors testing will be requested by a notified body.
- Do you have a Post Market Clinical Followup plan in place? If you have no historic clinical data on legacy products, notified bodies may accept PMCF data to supplement your file to meet the new MDR, but you need to start collecting that data now. Get your PMCF program up and running and start collecting data now that you can use for your CE marking to the new MDR by 2020.
- Can you really show technical, biological, and safety equivalence of your product to a competitors product? Notified bodies will now expect you to have all the technical documentation necessary to show equivalence, including design documentation, in order to claim equivalence. To put simply, you'd have to have access to your competitors complete DHF. Do you have a plan to show equivalence of your historic / legacy products to another companies product? If you can't do that, consider using PMCF now to obtain the data you need by 2020.
- Audit your QMS per ISO 13485: 2016. This comes first. Notified bodies are no longer certifying the previous revisions of ISO 13485. Many companies are obtaining their updated ISO certification first, and completing the technical file updates per their newest procedures. Provide this update plan to your notified body, along with your plan for updating your technical files. Van Hoven Consulting has a plan.
- Does your product meets the definition for a medical product in the EU?
- What class is your medical product?
- What Technical File content do you need to have for your new product?
- How to document compliance to recognized consensus standards?
- Content of Declarations of Conformity
- How to select the appropriate notified body?
- Does self-certification apply to my product?
- Determining the appropriate conformity assessment procedures for my new product.
- Determining if you have the appropriate quality system to support your product in the EU and elsewhere?
To discuss these and other aspects of CE marking your medical product, contact Van Hoven Consulting today.