by Steve Morgan
Within the European Union (EU), the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) is progressing to the original timescales as published by the EU.
The feared backlog of certifications to the new regulation is now beginning to appear as both medical device manufacturers and notified bodies begin the task of reviewing all technical files to the new directive.
The practical implications of the transition process on manufacturers are now becoming clearer and the purpose of this article is to review the current situation as applicable to medical devices in general and speciality contact lenses (CL’s) and intraocular lenses (IOL’s) specifically.
It is important to be clear about the timelines of the MDR introduction. The two key remaining dates are:
- 26th May 2020 Official application date of the MDR
- 25th May 2025 Date for which devices CE marked under the MDD can no longer be sold in Europe
Any medical devices which have not been approved to the MDR after this time cannot carry the CE mark and so cannot be placed on the market in the member states of the EU.
Let us consider some of the relevant aspects of MDR implementation at this stage of the transition process:
Background to the Development of the MDR
One of the key drivers in the development of the MDR was a perception that the current system under the MDD was losing its effectiveness in maintaining medical device safety. This was exacerbated by a number of high-profile medical device recalls and prosecutions, one outcome of which was a decision by the EU undertake a complete overhaul of the medical device regulations.
Impact on Notified Bodies
At the same time as the MDR was being drawn up, a review of the oversight and effectiveness of Notified Bodies (NB’s) was also conducted, principally lead by the national Competent Authorities (CA’s). The result of this review was the introduction of a more stringent set of controls for the assessment and ongoing monitoring of NB’s across the EU.
As a result, there has been a reduction in the overall number of NB’s operating within Europe and a rationalisation in the range and type of medical devices that NB’s are approved to certify.
Consequently, many manufacturers have been compelled to find alternative NB’s to conduct certification only to find that the remaining NB’s are not taking on new clients.
Currently, many NB’s are undergoing the MDR Notified Body (NB) designation process which needs to be successfully completed for a NB to be allowed to undertake certifications to the MDR. As of this date, only two NB’s have been designated to do this – BSi and TUV SUD.
All manufacturers should be in close contact with their NB’s to understand transition timing and whether any foreseen changes in the scope of the approval work undertaken.
Medical Devices Certified Under the Existing MDD
Current medical devices which have been certified to the MDD can continue to be placed on the market until the current certification expires or until May 2025, whichever occurs sooner. Recertification to the MDD is still being undertaken by some NB’s but the window of opportunity to do so is closing rapidly.
Continuing to place devices on the market under the MDD is not without risks:
- If the NB which certified the device under the MDD goes out of business as a result of not being designated to the MDR, then the existing certificates issued by that NB are no longer valid and no more devices can be placed on the market until recertification is completed.
- While devices are being placed on the market under the MDD, it is important to recognise that aspects of the MDR and other documents such as the MEDDEV’s will require manufacturers to comply with aspects of the new requirements, such as increased and periodic post-market surveillance and the reporting requirements on clinical safety and performance.
- Where NB’s are accepting recertification requests under the MDD, evidence suggests that the technical file needs to be faultless – any rejection for clarification or additional work to the technical file risks going over the transition date, at which point all MDD technical files in process will be rejected and a new submission to the MDR will have to be made.
Technical Files for the MDR
It is important to recognise that all technical files submitted for MDR certification will be fully reviewed, regardless of how many previous certifications under the MDD have been completed. As such, they will be treated as if it was the first submission and they will be assessed against all requirements of the MDR. As a result, all data and evidence will need to be directly related to the device in question and will have to reflect the “Generally acknowledged state of the art.” As such, the reuse of old and/or generic data is likely to be rejected, meaning that new testing is likely to be required for legacy products, regardless of their product history.
Specific Requirements for Clinical Evidence
The requirements of the MDR brings closer scrutiny on the clinical data provided in the technical file. The evidence needs to clearly support the claims being made of the device and must be relevant and current reflecting the MDR’s requirement for medical device manufacturers to meet “The generally acknowledged state of the art”.
In addition, the MDR now requires manufacturers to proactively seek information on the performance of their devices in the market throughout the lifecycle of the device. The information gathered needs to be reviewed and appropriate action taken to address not only specific non-conformities through corrective action but also the proactive monitoring of trends or the evidence which could indicate the potential for adverse events to occur. Each manufacturer will need to develop a PMS plan for each device type, outlining how effective post-market surveillance will be achieved. Regular safety update reports summarising the results of the PMS program will need to be prepared and added to the technical documentation under Quality Management System control.
Generally Acknowledged State of the Art
Under the MDR, medical device manufacturers are required to work to “the generally acknowledged state of the art”. This places a responsibility on the manufacturer to establish processes and mechanisms for ensuring their products reflect the given state of the art.
The term “Generally accepted State of the Art” can be interpreted as “best practices as used in other devices of the same or similar type.”
For a manufacturer to be able to demonstrate this to an auditor, it will be necessary to demonstrate that an external assessment of products already on the market with the same indications for use has been made and that the product for which certification is being sought has been assessed against these existing products.
The output of this assessment should form an input to the risk assessment activities of the device so that the risk – benefit calculations take into account existing products and their adverse event history. A comparison of the risk – benefit calculations of the new device against existing devices can then be used to support the argument for “State of the Art” compliance.
State of the art can also be assumed to relate to the processes and technology to produce the device if a clear link can be shown between these and patient benefit from using devices made with this technology and/or process.
While NB’s have had the right to conduct unannounced audits for some time, under the MDR NB’s will formalise this activity for all medical device manufacturers. Current evidence suggests that manufacturers should anticipate an unannounced audit approximately every three years or more frequently where adverse events have occurred.
Medical device manufacturers should plan and document processes for managing unannounced audits on the day, as well as for closing out follow up actions which may arise.
Key points to consider when establishing procedures to cover unannounced audits include (as a minimum):
- Identifying and documenting the key individuals within the company who will host the audit together with a list of deputies in the event that the original individual is not available.
- Communicating to all employees that unannounced audits should be expected and how to deal with them.
- Recognising that an unannounced audit will be conducted in a different way to an ISO 13485 audit and that the organisation should understand the differences and how to respond.
- Include in the process a requirement to confirm the auditor’s identities.
- Establishing a process to agree with the auditors the scope of the audit and areas that are in scope and those areas that are out of scope.
The MDR places heightened requirements on medical device manufacturers to manage supplier selection and control. Key considerations to note include:
- The level of impact the supplied product or service has on the finished device with regard to patient safety and regulatory compliance.
- Where a device manufacturer cannot demonstrate sufficient control proportionate to the criticality of the supplied product or service, it is more likely that the NB will wish to undertake an audit of the supplier.
- The costs for supplier audits by NB’s are borne by the manufacturer.
- Any non-conformities raised at the supplier audit are raised against the manufacturer, not the supplier.
- All manufacturers should undertake risk assessments of their suppliers to assess their impact on the device and its safety and regulatory compliance. All suppliers should be assessed, not just the most obvious ones.
- Formal supplier agreements should be established which include the requirement of suppliers to accept (unannounced or otherwise) audits by the device manufacturer and/or their notified body.
The introduction of the MDR continues to pose major challenges to medical device manufacturers, suppliers and Notified Bodies. Organisations that fail to understand the implications of these changes and who do not make appropriate plans, risk losing certification and therefore the right to place their medical devices on the market in the EU. The key message continues to be – talk to your Notified Body as soon as possible to ensure they can support the needs of your organisation and that they can help you transition smoothly to the new regulations.
Disclaimer – This article is intended for information only. It does not constitute an official or agreed position of Contamac Ltd. The views expressed are entirely those of the author.