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New Medical Device Regulations - Are you ready?

The new EU regulations for medical devices (MDR) and in-vitro diagnostics (IVDR) have been in development since 2012 and were given final approval for implementation on 5th April 2017. The regulations were formally published on 5th May 2017 and the obligations come into force 20 days later.
  •  In-Vitro Diagnostic Devices – Regulation (EU) 2017/746 (click here)
For the last 5 years industry players have been holding their breath in anticipation of these major changes. The situation is a reflection of the pharmacovigilance regulatory shake-up for human medicines that took place in 2012 and brought major changes the risk management of these products.
Like pharmacovigilance for human medicines, the legislation for medical devices had been around for over 25 years. With newer, more complex and innovative medical technologies creating a major shift in medical science, these regulations had become outdated and a radical update was required.
The objectives of the new legislation are to continue to ensure EU devices are safe, effective and produced to high standards. The regulations become effect at the end of May 2017 with certain mandatory obligations becoming effective within 6 months. Companies have been given a 3-year and 5-year transition period to align all medical devices (by end May 2020) and in-vitro-diagnostics (by end May 2022) with these new requirements, respectively.
The following key changes should be carefully considered:
  • Improved performance of notified bodies for medical devices
  • Qualifications of report authors and evaluators
  • Measureable objectives for the clinical evaluation report
  • Clarity about how to consider scientific validity of clinical data
  • Maintenance of the clinical evaluation report
  • Better pre-launch assessment of high-risk devices
  • Improved post marketing safety surveillance
  • Improved access to information on medical devices
High risk medical devices and drug-delivery devices will undergo further assessment under the new legislation, through the ‘scrutiny procedure’ in an effort to harmonise the assessment strategy of clinical data and ensure devices fit within a certain category. This additional level of assessment will be conducted by a panel of experts within the Medical Device Co-ordinating Group and will have 60 days to issue an opinion. The scrutiny procedure will apply to implantable class II devices and class IIb active devices used to administer and/or remove a medicinal product.
The June publication of the EU guidelines on Clinical Evaluation, MEDDEV 2.7/1, Revision 4 fall within the current EU guidelines and apply to the evaluation of all medical devices, regardless of classification. The clinical evaluation report (CER) is a summary of evidence collected from literature, market experience, pre-clinical and clinical data and includes a risk-benefit analysis to determine the safety profile of the product.

There are a number of control measures companies need to implement to manage these requirements:
  • Revise and update produral documentation and associated CER templates to align with MEDDEV 2.7/1 rev4.
  • Document qualifications of evaluators to show due diligence
  • Design a schedule to manage updating of CERs at required timeframes
  • Transition existing CERs to new template and format
  • Conduct internal audit of the CER process
With the release of MEDDEV 2.7/1, Rev 4 and now the new regulations, it is clear that authorities are not satisfied with the quality of clinical data provided to support medical devices. Furthermore, due to rapidly advancing technologies it is no longer sufficient to justify equivalence through competitor comparisons. A thorough analysis of equivalence will now be required.
The broader scope and increased controls aim to plug the gaps in the current legislation. The ultimate goal of which is to ensure devices are as safe as possible and that patients are aware of any risks associated with their use.

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