Marc Miller, Transperfect Medical Solutions12.11.19
By now, most in the medical device industry are familiar with the litany of issues associated with the implementation of the EU’s MDR. According to a RAPS/KPMG survey (from September, 2019), only 27% of respondents expect to be fully MDR compliant by the May 2020 deadline – and that number may be over-stated since many manufacturers are not completely aware of all the operational implications of this regulation.
Resource availability to support the industry’s transition to MDR has been a prominent issue: the most obvious example being Notified Bodies (NBs). As of November 25, there were seven designated NB’s - with 10 applications pending. To put this in perspective, seven NBs equals approximately 8% of the capacity under MDD, 17 equals approximately 32%. Dr. Bassil Akra, VP of TÜV SÜD has warned bluntly that even if 20 NBs are designated by May 2020, the workload will not be feasible (RAPS Regulatory Focus, 9/23/2019). The transfer and training of auditors from non-MDR NBs to designated NBs alone represents a significant, wrenching change.
At the end of October, the MDCG announced plans to release 50 guidance documents – although for more than 20 of these, the timing is still TBD. While regulatory guidance is welcome, bear in mind this is being done with only five months (or less) until the implementation deadline. Frequently, these guidance’s have run counter to industry assumptions (e.g. Patient Implant Cards) causing costly and time-consuming rework. At other times, they have sparked significant follow-on questions. Of course, delayed guidance and subsequent clarifications are another impediment to timely implementation.
Understandably, manufacturers have pushed back on these unrealistic requirements through various trade associations. MedTech Europe sent an open letter to the EC on April 15th of this year outlining their concerns. More recently, they issued a stark warning about the state of un-readiness for MDR implementation. As a 28-year supplier to the medical device industry, TransPerfect Medical Device Solutions sent a similar open letter to the EC outlining the risks presented by the MDR’s labeling requirements under the current timetable. It is simply not feasible for the entire industry to implement the required number of changes to EN and translated documentation in five months, given the fact that 99% of manufacturers still work in document-based systems (Word, InDesign, FrameMaker) that must be manually updated and QC’d. On top of this, manufacturers often have their own requirements for internal QC (e.g. in-country review of translations) that they are unwilling or unable to abandon or modify – even under circumstances of dire need, such as we now face with MDR.
Fundamentally, there are two major obstacles to implementing a regulatory change of this scale and scope for the device industry. They are structurally inherent and therefore are nobody’s “fault” per se. However, they still exist and therefore must be considered in light of the time required for effective implementation:
Industry Approach
As a highly regulated industry, there is an inherent conservatism to the medical device industry. Software requires validation, critical suppliers are subject to Notified Body control, documented processes must undergo a specific change management process, etc. All of these controls are meant to ensure product quality and effectiveness and protect patient safety. However, when faced with a sweeping regulatory overhaul, this “conservative” approach demands increased timelines for effective change-management...and only after regulatory requirements have been well-defined. Often, tools and processes are not state-of-the-art (e.g. document-based applications for labeling) for this very reason: there is an aversion to dramatic change because strict controls make change difficult to implement across the organization.
Industry Structure
The other inherent issue facing the device industry is the organizational structure of the typical medium-to-large manufacturer. Most of these manufacturers have grown through acquisition and operate more as a “family of companies” than a single-enterprise entity. Most acquired companies retain their original quality systems because it is too difficult to unify controls for different operations and processes that produce various devices for different treatment areas. Again, this makes enterprise-wide regulatory changes problematic due to competition for corporate resources as well as varying processes and procedures; there is no viable templated approach because requirements and processes vary so widely.
What Does it Mean?
In short, this is not good news for the medical device industry, nor is it good news for EU patients – the current circumstances represent a perfect storm of massive regulatory change, conservative industry approach, and a corporate organizational structure that is generally ill-suited to accommodate a hyper-compressed implementation timeline. The consequence of the EC’s delayed, piecemeal MDR implementation is that many manufacturers will not be adequately prepared by the May 2020 deadline. If substantive relief is not provided by the EC in the near future (Q1, 2020), EU patients may be facing shortages of critical medical devices or increased device risk due to increased resource (supplier) and process risk (in turn, due to timeline pressures). This was certainly not the intent of the MDR – but it is without a doubt the effect of the regulation’s implementation in the face of the industry’s inherent characteristics.
Marc Miller is the Division President of TransPerfect Medical Device Solutions. For over 28 years, he has assisted all sizes and types of device manufacturers with translation and process automation for Labeling, Marketing, e-Learning, Software, and other product-related content. Marc founded the first translation company certified to ISO 13485 and ISO 14971 and is the co-author of the industry's only translation risk management patent. He also lead the development of the first content automation system specifically designed to meet MDR and IVDR content requirements. Marc holds his BA from Harvard University and his MBA from Stirling University in Scotland.
Resource availability to support the industry’s transition to MDR has been a prominent issue: the most obvious example being Notified Bodies (NBs). As of November 25, there were seven designated NB’s - with 10 applications pending. To put this in perspective, seven NBs equals approximately 8% of the capacity under MDD, 17 equals approximately 32%. Dr. Bassil Akra, VP of TÜV SÜD has warned bluntly that even if 20 NBs are designated by May 2020, the workload will not be feasible (RAPS Regulatory Focus, 9/23/2019). The transfer and training of auditors from non-MDR NBs to designated NBs alone represents a significant, wrenching change.
At the end of October, the MDCG announced plans to release 50 guidance documents – although for more than 20 of these, the timing is still TBD. While regulatory guidance is welcome, bear in mind this is being done with only five months (or less) until the implementation deadline. Frequently, these guidance’s have run counter to industry assumptions (e.g. Patient Implant Cards) causing costly and time-consuming rework. At other times, they have sparked significant follow-on questions. Of course, delayed guidance and subsequent clarifications are another impediment to timely implementation.
Understandably, manufacturers have pushed back on these unrealistic requirements through various trade associations. MedTech Europe sent an open letter to the EC on April 15th of this year outlining their concerns. More recently, they issued a stark warning about the state of un-readiness for MDR implementation. As a 28-year supplier to the medical device industry, TransPerfect Medical Device Solutions sent a similar open letter to the EC outlining the risks presented by the MDR’s labeling requirements under the current timetable. It is simply not feasible for the entire industry to implement the required number of changes to EN and translated documentation in five months, given the fact that 99% of manufacturers still work in document-based systems (Word, InDesign, FrameMaker) that must be manually updated and QC’d. On top of this, manufacturers often have their own requirements for internal QC (e.g. in-country review of translations) that they are unwilling or unable to abandon or modify – even under circumstances of dire need, such as we now face with MDR.
Fundamentally, there are two major obstacles to implementing a regulatory change of this scale and scope for the device industry. They are structurally inherent and therefore are nobody’s “fault” per se. However, they still exist and therefore must be considered in light of the time required for effective implementation:
Industry Approach
As a highly regulated industry, there is an inherent conservatism to the medical device industry. Software requires validation, critical suppliers are subject to Notified Body control, documented processes must undergo a specific change management process, etc. All of these controls are meant to ensure product quality and effectiveness and protect patient safety. However, when faced with a sweeping regulatory overhaul, this “conservative” approach demands increased timelines for effective change-management...and only after regulatory requirements have been well-defined. Often, tools and processes are not state-of-the-art (e.g. document-based applications for labeling) for this very reason: there is an aversion to dramatic change because strict controls make change difficult to implement across the organization.
Industry Structure
The other inherent issue facing the device industry is the organizational structure of the typical medium-to-large manufacturer. Most of these manufacturers have grown through acquisition and operate more as a “family of companies” than a single-enterprise entity. Most acquired companies retain their original quality systems because it is too difficult to unify controls for different operations and processes that produce various devices for different treatment areas. Again, this makes enterprise-wide regulatory changes problematic due to competition for corporate resources as well as varying processes and procedures; there is no viable templated approach because requirements and processes vary so widely.
What Does it Mean?
In short, this is not good news for the medical device industry, nor is it good news for EU patients – the current circumstances represent a perfect storm of massive regulatory change, conservative industry approach, and a corporate organizational structure that is generally ill-suited to accommodate a hyper-compressed implementation timeline. The consequence of the EC’s delayed, piecemeal MDR implementation is that many manufacturers will not be adequately prepared by the May 2020 deadline. If substantive relief is not provided by the EC in the near future (Q1, 2020), EU patients may be facing shortages of critical medical devices or increased device risk due to increased resource (supplier) and process risk (in turn, due to timeline pressures). This was certainly not the intent of the MDR – but it is without a doubt the effect of the regulation’s implementation in the face of the industry’s inherent characteristics.
Marc Miller is the Division President of TransPerfect Medical Device Solutions. For over 28 years, he has assisted all sizes and types of device manufacturers with translation and process automation for Labeling, Marketing, e-Learning, Software, and other product-related content. Marc founded the first translation company certified to ISO 13485 and ISO 14971 and is the co-author of the industry's only translation risk management patent. He also lead the development of the first content automation system specifically designed to meet MDR and IVDR content requirements. Marc holds his BA from Harvard University and his MBA from Stirling University in Scotland.
