Global Regulatory Pulse

EU Commission Issues Supplementary Guidance Information for CE Marks Under MDR & IVDR

In Consulting, European Market, Regulatory by Dr. Vincent Legay

Since the approval of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) by the EU Commission on 5 April 2017, the lack of substantive guidance has hindered manufacturers’ preparation to ensure they properly address new regulatory expectations by the mandatory conformity dates of May 2020 and May 2022, respectively.

Fifteen (15) months after the adoption of the regulations, the EU Commission has issued the following “Information to Manufacturers” in an effort to provide further clarity on new regulatory changes and implementation models to address the regulations:

Medical Devices

In-Vitro Diagnostics

The above documents are in line with the plans and guidance that have been prepared by numerous organizations in the absence of “official” guidance information from the EU Commission, and reference the FAQ documents previously issued by the CAMD (Competent authorities for Medical Devices).

The publication of these EU Commission documents reemphasize the urgency with which manufacturers must act to ensure they will be ready for the MDR and IVDR. The implementation models included within these documents will be helpful to those manufacturers well on their way to addressing MDR/IVDR activities to verify that all relevant issues are being addressed. For those manufacturers yet to take appropriate action to transition by 2020/2022, these new guidance documents present valuable checklists to be urgently undertaken.

There remains a large number of steps required before the date of application of the MDR and IVDR, including implementing/delegating acts and practical guidance documents, and NAMSA will continue to monitor their progress and inform clients as soon as new documents are issued.

These documents pursue the objective of ensuring uniform application of the relevant provisions of the regulations within the EU and address:

  • stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
  • the reinforcement of the criteria for designation and processes for oversight of Notified Bodies
  • the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations
  • the introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance
  • improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification
  • the introduction of an “implant card” containing information about implanted medical devices for a patient
  • the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
  • the strengthening of post-market surveillance requirements for manufacturers
  • improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance

Additional information may be found on the EU Commission’s website here.

How can NAMSA Help?
Navigating the international regulatory landscape can be overwhelming for any medical device manufacturer. That’s why having the right partner, at the right time, can be invaluable in achieving reimbursement requirements and market success.

NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. In fact, our internal teams of medical device development experts communicate with EU entities nearly every day.  Our teams are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. This expertise has been proven to save medical device organizations up to $17M in costs and 23 months in development timelines (access our client testimonials here).

If you are interested in speaking with us about EU-related activities or other global regulatory strategies, please contact us at: communications@namsa.com or 1-419-666-9455. You may also visit our regulatory consulting webpage here.

Authors:

Vincent Legay holds a PhD in Biology and an executive Masters of Business Administration (MBA), and currently serves as NAMSA’s Global Director of Product Development Strategic consulting services. He possesses over 15 years’ experience at NAMSA where he has been responsible for regulatory consulting across the entire medical device lifecycle continuum. This expertise includes management of sterilization, biocompatibility, risk management, clinical evaluation and quality management systems for clients around the globe. Currently, he oversees a team of worldwide strategic consultants and also directly supports medical device manufacturers with preclinical and clinical research approaches in an effort to meet regulatory business objectives, with a focus on MDR 2017/745.