EU Medical Device Regulation
KNOWLEDGE CENTER

EU MDR: How ready are you?

EU Medical Device Regulation (MDR) is already in force and with full application of the MDR is coming into effect in May 2020. The time is ticking for the device manufacturers to ensure data, documentations, processes and systems meet requirements. EU MDR comes up with some significant changes which will affect device manufacturers. It is very important for manufacturers to understand these changes and their implications to them in order to be compliant and maintain CE certificate. Time required and associated cost of compliance will be significant, therefore, it is critical that manufacturers proactively take necessary steps to implement the required changes and brace for any upcoming challenges coming their way.

Medical Device Regulation

New EU MDR changes and implications for device manufacturers are summarized below:

Re-Classification

Change Description

  • Certain products have received special consideration in the MDR and are subject to reclassification. (MDR Article 4).
  • These new provisions variously apply to cosmetic implants, standalone software, products without an intended medical purpose (MDR Annex XVI), certain spine products and reusable Class 1 devices.

Implications for Device Manufacturer

  • Manufacturers should carefully examine the MDR Classification rules in Annex VIII to determine whether new conformity assessment routes are now applicable to their product portfolio.
  • If so, they should engage their Notified Body and take necessary steps to ensure that all requirements are met in specific time frame.

Market Access of Legacy Products

Change Description

  • All products have to be CE marked under the new Regulation 2017/745, in order to be placed on the market or put into service (MDR Article 5), after the transition period.
  • There is no provision for grandfathering certification (CE marks) obtained under the previous Directives.

Implications for Device Manufacturer

  • A comprehensive plan needs to be put in place to ensure that all products that will be maintained on the EU market are CE marked in accordance with the full requirements of the new MDR.
  • This should include products currently under development. This review may provide an opportunity for rationalization of the product portfolio and elimination of any marginal products.

Technical Documentation

Change Description

  • The MDR is significantly more prescriptive about the required content of technical documentation (Technical File/Design Dossier).
  • Essential Requirements (ERs) are replaced by “General Safety Requirements (MDR Annex I) and the number of requirements has been expanded. Additionally, there are more.

Implications for Device Manufacturer

  • The required technical file/design dossier documentation is heavily based on the current GHTF STED Guidance document reflecting the harmonization intent of global regulators. Accordingly, the continuing sufficiency of the Technical File/Design Dossier including associated checklists will need to be checked in detail.
  • Manufacturers will need to remain alert to the publication on new Common Specifications. In addition, manufacturers should be aware of a new Subsection related to required Post Market Surveillance (PMS) information.

Clinical Evaluation

Change Description

  • The MDR is more specific about the need for clinical evidence and clinical evaluation, proportionate with the risk associated with a given device (MDR Annex XIV, Part A).
  • Reliance on the scientific literature to demonstrate equivalence will be more tightly regulated, and clinical evaluations will be more closely aligned with clinical trials associated with medicinal products.

Implications for Device Manufacturer

  • This may require manufacturers to obtain additional clinical data from clinical studies. There will be additional scrutiny of Clinical Evaluation Reports (CERs) by Notified Bodies as outlined by new guidance (MEDDEV 2.7.1 rev. 4).
  • With MDR, the equivalence is going to be tough and less accepted. The equivalence route for devices is only possible with the manufacturer’s owned other devices with demonstration of technical, biological, and clinical characteristics as described
  • Manufacturers should plan to review all of their CERs if not reviewed within the last 1-2 years and ensure that CERs include Post Market Surveillance data; especially where devices are new to market and where clinical data was limited at the time of first CE Marking.

Vigilance and Post Market Surveillance (PMS)

Change Description

  • Under the new Regulation 2017/745, device manufacturers will be required to collect post-market clinical data as part of their on-going assessment of potential safety risks.
  • Post Market Clinical Follow up (PMCF) is a continuous process with the objective of constantly updating the clinical evaluation (MDR Annex XIV, Part B).
  • Additionally, reporting timeframes are tightened from 30 days to 15 days for reporting serious incidents (MDR Article 87).
  • There will be new electronic vigilance reporting (MDR Article 92) and Periodic Safety Update Reports (PSUR) for all devices (MDR Article 86) subject to differing frequency and submission requirements.

Implications for Device Manufacturer

  • Manufacturers need to review their procedures for PMS and ensure that the responsibility for the provision of this additional data and associated support is clearly established.
  • This is likely to require additional resources in functions that support products on the market such as Regulatory and Medical Affairs.

Labeling

Change Description

  • Requirements for product labeling are more prescriptive under MDR than before. For example, information supplied by the manufacturer shall be made available and kept up to date on the manufacturer’s website (MDR Chapter III, 23.1).

Implications for Device Manufacturer

  • Manufacturers should carefully review the adequacy of their product labeling and precautionary statements and consider how this will be reflected on their websites.

As these new EU MDR changes spread across different areas, processes and systems, the device manufacturers need to take a more holistic approach to deal with them than taking an isolated approach to ensure complete compliance to EU MDR. They need to have well- thought strategies, roadmap, supported by adequate resources to implement these changes across their products, processes and internal systems.

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