News: Regulations & Standards

Julia Forjanic Klapproth, Senior Partner at Trilogy Writing & Consulting receives the Harold Swanberg Distinguished Service Award 2022

November 2022

Trilogy Writing & Consulting, a company specialised in regulatory writing, announced that one of its Senior Partners, Julia Forjanic Klapproth, was honored with the Harold Swanberg Distinguished Service Award during the American Medical Writers Association (AMWA) conference that took place in Denver, CO, in the beginning of November 2022.

The Harold Swanberg Award, named after one of the founders of AMWA, is presented to an active AMWA member who has made distinguished contributions to medical communication or rendered unusual and distinguished services to the medical profession.

In her acceptance speech, Julia reminiscences the earlier years of her career and shares her insights on how medical writers and communicators are a pivotal part of the development of science and society at large: “The better we do our job, the faster the messages of today will drive the science and developments of tomorrow and improve the lives of people throughout the world. We saw so clearly during the pandemic the importance of getting clear messages out to the world to avoid confusion and mistrust in science. So, I honestly do not believe it is an exaggeration when I say that medical writers bring the light to the world. Hard won light gleaned by researchers, doctors, and patients who commit to research so we can learn more. But it is we who tell the world what has been learned.”

This award is a recognition of Julia’s “almost obsessive passion for medical writing and its importance to the pharmaceutical industry and the world.”

To listen to Julia’s acceptance speech, please click HERE

To learn more about AMWA, please visit


Trilogy Writing & Consulting gains PIF TICK accreditation to be recognised as a ‘trusted information creator’

August 2022 Trilogy Writing & Consulting has been awarded the PIF TICK – the UK’s only assessed quality mark for print and online health and care information. To be awarded the ‘trusted information creator’ status, Trilogy had to undergo an assessment showing it met 10 key criteria. This means you can be assured that what you are reading, watching, or listening to is evidence-based, understandable, jargon-free, up-to-date, and produced to the best possible standard. Lisa Chamberlain James, Senior Partner at Trilogy Writing & Consulting, said: “Gaining the PIF TICK shows we have a strong process for developing our clinical and scientific communication documents. It is clear that the demand and need for information for the non-specialist audience is growing, and it is equally clear that with the current information overload it is difficult to know what to trust. This quality mark is an unequivocal way for people to be assured our information is reliable and trustworthy.” The PIF TICK, which launched in May 2020, is run by the non-profit Patient Information Forum (PIF). In July 2021, a public website,, was launched to raise awareness of PIF TICK-accredited members and help people find trusted health information. The site also includes guides on topics including spotting false health information and understanding evidence. PIF TICK manager Dan Wills said: “We are thrilled to welcome Trilogy Writing & Consulting to our ever-growing community of accredited PIF TICK members. Accurate, accessible, evidence-based information is key to increasing patient empowerment and improving health outcomes.” For more information, please go to:

The Consequences of EU Regulation 536/2014​

February 2022

The way clinical trials are conducted in the European Union (EU) will undergo a major change when the portal for upload of the lay summaries required by Clinical Trials Regulation (Regulation (EU) No 536/2014) opens on 31 January 2022. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS will contain the centralised EU portal and database for clinical trials required by the Regulation. The European Medicines Agency (EMA) sets up and maintains CTIS, in collaboration with the Member States and the European Commission.

The goal of the Clinical Trials Regulation is to create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information. The Regulation will require:
• Consistent rules for conducting clinical trials throughout the EU,
• Information on the authorisation, conduct and results of each clinical trial carried out in the EU to be publicly available.
This will increase the efficiency of all trials in Europe with the greatest benefit for those conducted in multiple Member States. It aims to foster innovation and research, while helping avoid unnecessary duplication of clinical trials or repetition of unsuccessful trials.

With the opening of the portal for upload of Clinical Trial Lay Summaries, the requirement for Lay Summary production is about to become mandatory. Sponsors will be required to submit a summary of the clinical trial results to the publicly available European database 12 months after the end of the trial.

The Medical Devices Regulations (MDR) of 2017 increased the requirements for documentation of clinical data in support of License Applications

Prior to 1993, documentation of a medical device’s clinical safety and performance was given much less attention than the documentation of its manufacture and quality. Since June 1993 a series of regulatory efforts were made to improve the safety of medical devices.

MDD = Medical Devices Directive (93/42/EEC); MDR = Medical Devices Regulations (2017/745)

In April 2017, the MDR was released and made the clinical evaluation of medical devices statutory for access to the EU market for all classes of Medical Devices. Although new guidelines derived from the MDR are expected, including guidance on specific types of devices, the MEDDEV guidelines relating to the clinical evaluation have remained largely valid. The MDR strengthened the requirement for the clinical evaluation of medical devices, particularly the need for a thorough documentation of pre-clinical and clinical data relating to the safety and performance of the device. The amount of pre-clinical and clinical data required for documentation depends largely on the level of risk to health and safety associated with the use of the device. Several new document types have been introduced:

  • Clinical Evaluation Report (CER)
  • Clinical Development Plan (CDP)
  • Clinical Evaluation Plan (CEP)
  • Post-market Clinical Follow-up (PMSF) Plan
  • PMSF Report
  • Failure Modes and Effects Analysis (FMEA)
  • Clinical Investigation Plan
  • Clinical Investigation Report


Not all these are required for all devices but a CER is now mandatory for all medical device license applications in Europe. For the regulators (Notified Bodies), the CER is a key element in assessing the fitness of a medical device for clinical use.

Details on the requirements of the clinical evaluation of a medical device were first provided in the MDD but details on the content of the CER first appeared in the EU MEDDEV Guideline 2.7/1 rev 4 (2016). It documents the clinical evidence that supports a licensing application and, after approval, it is regularly updated to enable the device to remain on the market.

The CER describes the clinical evaluation of the medical device and, according to the MDR 2017, “… shall be thorough and objective, and take into account both favourable and unfavourable data. Its depth and extent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer’s claims in respect of the device.”

The CER is a stand-alone document and is submitted as an attachment to the Technical File. It contains:

  • an assessment of the evidence of the device’s safety risks and expected clinical performance, and, in the updates, additional clinical data on its safety and performance in the field, using evidence actively acquired by the manufacturer during the post-marketing clinical follow-up,
  • a regularly updated review of relevant published literature, and,
  • depending on the class and type of device, data from clinical investigations of the device.

The EU MEDDEV Guideline 2.7/1 rev 4 (2016) remains the currently accepted guidance on the processes of clinical evaluation of medical devices and includes guidance on the structure and content of the CER. It proposes a table of contents for the CER that is now widely accepted as the standard.