Medical Writing Services – the explanation
IMed’s Medical Writing service (sometimes also called ‘Clinical Writing’) is provided by Medical Writing experts. This is important, because not just anyone can write and sign off a Clinical document in support of your medical device, if it’s to be accepted by the Regulatory Authorities or Notified Body;
MEDDEV 2.7.1 rev.4. states;
“The evaluators should have at least the following training and experience in the relevant field: – a degree from higher education in the respective field and 5 years of documented professional experience; or – 10 years of documented professional experience if a degree is not a prerequisite for a given task.”
So, what is medical writing?
Medical writing involves creating well-structured scientific documents, based on clinical research that relates to your medical device. These documents are a requirement of one of the European Union’s Regulations related to the medical products: Medical Device Regulation (MDR 2017/745) and In-Vitro Diagnostic Medical Device Regulation (IVDR 2017/746) or Section 501(k) from the FDA in North America and must, understandably, be completed by an appropriately qualified professional.
When would I need these services?
Your medical device is required to have a Clinical Evaluation, which will assess and analyse clinical data to verify and document the clinical safety and performance of the device.
You will need this initially to CE-mark. Then throughout the life cycle of the device, you will need to update the document. For high-risk devices, you’ll need to do this every year and for lower risk devices, at least every 2-4 years. And, if your post-market surveillance detects any specific risks from the device, you would be required to reflect these in the document, as events occur.
Other services such as scientific publications or clinical literature reviews will also be critical if you are trying to get a new technology or device to market, or if your marketed device has very limited literature available. An experienced Medical Writer can provide critical analysis of scientific data and use their well-honed academic research skills, to create eloquent, factual and comprehensive documents, essential to getting your device to market.
Clinical Evaluation Plans (CEP) & Reports (CER)
It’s the responsibility of the Medical Writer on your project to organise and interpret clinical data to be presented to regulatory authorities. Initially they would identify the reports required to comply with MDR/IVDR or your desired standard/market;
- CEP describes scope, objective and methodology
- CER shows the results, analysis and conclusions
These are required documents for market approval of any medical device to be sold in the UK, Europe, USA, China and Australia and are needed to document the conclusions on benefit-risk ratio, safety and performance of the device, gathered from clinical data collected from either clinical investigations, published articles or other studies. CEPs and CERs are needed;
- as a regulation requirement to have an ongoing process
- as a requirement to be regularly updated throughout the device’s life cycle
- for review by your notified body and regulatory authorities
Clinical Literature Reviews
A Clinical Literature Review (CLR) can be produced independent of the CER to strengthen a medical device’s portfolio by conducting a thorough search and comprehensive synthesis of all literature currently available on the product. A CLR is specified in FDA guidance as a requirement to demonstrate safety and efficacy, but it can also serve the same purpose with EU and UK regulatory bodies as it:
- Provides important information for product development
- Provides insight into competitor devices and how they may compare
- Provides evidence to substantiate current clinical indications
- Identifies “off-label” uses or adverse event data
Periodic Safety Update Reports (PSURs) & Post-Market Surveillance Reports (PMSRs)
PSURs and PMSRs report the practice of monitoring the safety of a medical device after it’s been released on the market. Again, these documents are crucial because it’s a requirement of the MDR and IVDR. PSURs are required for class IIa and up, with PMSR for class I devices only.
IMed’s Medical Writers have experience with all kinds of Clinical Writing over numerous types of medical device AND within various therapeutic areas. You can leverage their expertise with:
- Medical writing support or peer review of CERs by a qualified evaluator
- Preparation of CEP/CER (including multiple variants) for CE-marking
- Gap analysis (such as MDD to MDR, MEDDEV 2.7.1 rev3 to rev4)
- SOP writing
- Template guidance
- Update of existing CER
- Scientific Publications
- Systematic reviews
If you have a Medical Writing query or task to get to grips with, please get in touch with IMed now and we’ll get you talking to our Senior Medical Writer, Ana Quinn, who can advise you on and deliver the documents that you need. Contact us now on 01295 724286 or send us an email to firstname.lastname@example.org.
RA & Clinical Consultant