Scott Edwards, Managing Director, Solutions Delivery, Maetrics12.18.18
As manufacturers work toward complying with the new Medical Device Regulation, they are highly likely to encounter significant hurdles along the way. One area of concern is the Clinical Evaluation Report (CER), which is required in every device’s technical file. Manufacturers are struggling to figure out how much time is needed and whether they have the necessary resources to get their CERs right. This article outlines actions manufacturers can take to facilitate the process of drafting CERs and keep them maintained.
Challenge #1: Time
The key to devising a realistic CER plan is to factor in ample time. A systematic CER can take up to three months to finalize; this is dependent on the availability of data and resources. It is worth taking the time to carry out each CER as thoroughly as possible, as later updates following an inspection could prove even more time consuming and costly. Manufacturers that have already drafted CERs according to the guidance in MEDDEV 2.7/1 Rev. 3 must not be complacent as the fourth revision of the document makes a significant leap, requiring more than just a routine update to CERs.
Streamlining Procedures
To make the CER process more efficient, businesses must develop standardized procedures for gathering all the required inputs to CERs. The aim should be to create a system enabling all the necessary information to be accessed at the right time, in the right format. For writing the report itself, manufacturers should have detailed templates and standard text for staff to re-use for each new CER, rather than starting from scratch. Building these internal resources may require assistance from experienced compliance specialists who can rapidly identify gaps and suggest remedies. In the long-term, standardized procedures will contribute to valuable time savings, and manufacturers should look to further streamline their procedures; for instance, it may be possible to consolidate devices under a single CER.
Challenge #2: Expertise
The industry as a whole is under pressure with the need to meet new regulations. Add to that an increasingly competitive landscape to find compliance talent. As a result, sourcing expertise has become another serious challenge for manufacturers. CERs have to be carried out by qualified and accredited individuals who have knowledge of the device and therapy areas as well as knowledge of the research methodology along with critical review skills.
Training Personnel
One option is to develop in-house expertise. Manufacturers can take advantage of the training courses available on CERs and related topics, such as research methodologies, to help develop the knowledge to review CERs and learn how to manage the process effectively. Medtech businesses need to develop internal procedures for QMS that stem from a clear understanding of the inputs required for the clinical evaluation; this is another area of expertise required. Ensuring you have personnel who are able to develop standard operating procedures (SOPs) for the CER is also key. Creating comprehensive and standard templates so that evaluators are equipped to consistently follow the correct process and avoid discrepancies is an important part of effective CER management.
To approach the CER efficiently and reduce time spent to complete it, savvy manufacturers will allocate certain elements of the process to different (appropriately trained) internal or external personnel. Data extraction doesn’t necessarily need to be carried out by the CER author and can be completed by someone who has that specific skill set. Analyzing the skill sets among available personnel and assigning parts of the CER on that basis can reduce time and increase quality; often the author is required to collate data that would more effectively be produced by others, such as equivalent device product data, which would be better provided by the technical team.
Maximizing Resources
Ensuring there are enough dedicated staff available (factoring in potential workloads) is critical to help ensure CERs are completed to the right standard and within the time frame required. Many companies are looking to tap into external expertise to help them manage the peaks in CER writing and updates. The advantage to finding a balance between insourced and outsourced personnel is it allows internal teams to stay focused on the day-to-day workloads and managing the CER program while the external team focuses on execution and delivery. The demands of writing and updating CERs becomes less burdensome internally, yet still allows the internal team oversight of CERs.
The Business Case
For products that are already on the market, CERs are made easier if businesses carry out ongoing post-market surveillance and risk management. This is why it is important to have clear procedures and strategies in place; without any planning, manufacturers will have to make a last minute dash to collate the information needed. Notified bodies are under increased pressure due to the MDR and regulatory requirements for clinical data are more demanding, so there is no scope for leniency. A failed CER inspection may result in businesses having to take their products off the market, damaging brand reputation and necessitating costly remediation. On the other hand, a proactive approach positions businesses ahead of competitors, and ensures they are well placed to face future regulatory developments and challenges.
Scott Edwards is managing director, solutions delivery at Maetrics LLC, with experience in technical and managerial aspects of the medical device industry. He is a seasoned leader directing large quality system remediation and improvement programs. Edwards is one of Maetrics’ project leads for EU MDR, MDSAP, and ISO 13485:2016 solutions and is currently supporting several clients on global remediation programs for implementing the new international regulatory requirements. Prior to Maetrics, Edwards was the director of quality assurance and regulatory affairs for AMD Lasers and has significant experience in quality system consulting.
Challenge #1: Time
CER Checklist It is expected that the manufacturer will demonstrate:
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Streamlining Procedures
To make the CER process more efficient, businesses must develop standardized procedures for gathering all the required inputs to CERs. The aim should be to create a system enabling all the necessary information to be accessed at the right time, in the right format. For writing the report itself, manufacturers should have detailed templates and standard text for staff to re-use for each new CER, rather than starting from scratch. Building these internal resources may require assistance from experienced compliance specialists who can rapidly identify gaps and suggest remedies. In the long-term, standardized procedures will contribute to valuable time savings, and manufacturers should look to further streamline their procedures; for instance, it may be possible to consolidate devices under a single CER.
Challenge #2: Expertise
The industry as a whole is under pressure with the need to meet new regulations. Add to that an increasingly competitive landscape to find compliance talent. As a result, sourcing expertise has become another serious challenge for manufacturers. CERs have to be carried out by qualified and accredited individuals who have knowledge of the device and therapy areas as well as knowledge of the research methodology along with critical review skills.
Training Personnel
One option is to develop in-house expertise. Manufacturers can take advantage of the training courses available on CERs and related topics, such as research methodologies, to help develop the knowledge to review CERs and learn how to manage the process effectively. Medtech businesses need to develop internal procedures for QMS that stem from a clear understanding of the inputs required for the clinical evaluation; this is another area of expertise required. Ensuring you have personnel who are able to develop standard operating procedures (SOPs) for the CER is also key. Creating comprehensive and standard templates so that evaluators are equipped to consistently follow the correct process and avoid discrepancies is an important part of effective CER management.
To approach the CER efficiently and reduce time spent to complete it, savvy manufacturers will allocate certain elements of the process to different (appropriately trained) internal or external personnel. Data extraction doesn’t necessarily need to be carried out by the CER author and can be completed by someone who has that specific skill set. Analyzing the skill sets among available personnel and assigning parts of the CER on that basis can reduce time and increase quality; often the author is required to collate data that would more effectively be produced by others, such as equivalent device product data, which would be better provided by the technical team.
Maximizing Resources
Ensuring there are enough dedicated staff available (factoring in potential workloads) is critical to help ensure CERs are completed to the right standard and within the time frame required. Many companies are looking to tap into external expertise to help them manage the peaks in CER writing and updates. The advantage to finding a balance between insourced and outsourced personnel is it allows internal teams to stay focused on the day-to-day workloads and managing the CER program while the external team focuses on execution and delivery. The demands of writing and updating CERs becomes less burdensome internally, yet still allows the internal team oversight of CERs.
The Business Case
For products that are already on the market, CERs are made easier if businesses carry out ongoing post-market surveillance and risk management. This is why it is important to have clear procedures and strategies in place; without any planning, manufacturers will have to make a last minute dash to collate the information needed. Notified bodies are under increased pressure due to the MDR and regulatory requirements for clinical data are more demanding, so there is no scope for leniency. A failed CER inspection may result in businesses having to take their products off the market, damaging brand reputation and necessitating costly remediation. On the other hand, a proactive approach positions businesses ahead of competitors, and ensures they are well placed to face future regulatory developments and challenges.
Scott Edwards is managing director, solutions delivery at Maetrics LLC, with experience in technical and managerial aspects of the medical device industry. He is a seasoned leader directing large quality system remediation and improvement programs. Edwards is one of Maetrics’ project leads for EU MDR, MDSAP, and ISO 13485:2016 solutions and is currently supporting several clients on global remediation programs for implementing the new international regulatory requirements. Prior to Maetrics, Edwards was the director of quality assurance and regulatory affairs for AMD Lasers and has significant experience in quality system consulting.