Two sides of the regulatory coin

One of the most rewarding aspects of regulatory work is that no two days are the same. There are always new (and constantly evolving) technologies and regulations to provide fresh opportunities to show your skills. If you’ve been tied up trying to get ready for May 26, 2020 and missed the new documents published in the last month, we thought we'd provide you with a short summary of what has been published recently. As we at R&Q well know, the other side of the [rewarding work] coin is that it can be awfully challenging to keep up! We hope you find this helpful and if you'd like to see more posts like this, definitely let us know.

EU MDR/IVDR news

Acronym you need to know: CAB = Conformity Assessment Bodies

You’ll need the acronym above to read the latest EU MDR guidance document for notified bodies.

Key takeaways:

• Guidance documents aren’t compulsory but notified bodies do have liability, and the courts often lean on them (translation: follow the guidance)
• All reviews are new to EU MDR and must be complete 

• • No pre-certification activities (can’t ask notified body to pre-look at sections)
  • No submissions prior to designation of the notified body to EU MDR
  • No allowance for existing MDD certificate (can’t do a “gap” review to new MDR requirements)

• Confirms that OBL (own brand labeling) or OEM (original equipment manufacturer) are not defined in the EU MDR; the manufacturer on the label has full responsibility of all the requirements for the EU MDR
• Audit of manufacturer must include audit of subcontractors/suppliers based on criticality
• Clarification on what activities might be considered “consultancy” and therefore not allowed for the notified bodies along with clarification on potential conflicts of interest
• CER writers may be interested in question IV.6 regarding the internal or integrated clinician and when external expert clinical opinions may be needed for assessment of the CER

Designated notified bodies:

BSI UK – Note they recently sent out a client communication stating they are accepting EU MDR applications (click here for scope)

• Pending Annex XVI device common specifications being issued

TUV SUD – Received designation in May 2019 (click here for scope)

• Excludes some breast implants and reprocessed devices that aren’t foreseen by the manufacturer to be reprocessed

FDA

FDA has been busy issuing new guidance documents:

New Pilot for Software:

• Digital Health Software Pre-certification (Pre-Cert) Program: Participate in 2019 Test Plan
• Requires full review for this but may be useful in future submissions to help streamline review process

General Guidance

• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
  • Enhanced pre-submission acceptance checklist
  • Sponsor identifies at least 3 specific meeting dates and FDA responds to accept or propose two alternative dates; meeting date assigned within 30 days of meeting request
  • More examples of FAQ that produce productive meetings
  • 70 day target for feedback on submission and at least five days in advance of the planned meeting for pre-subs
  • Example template for meeting minutes

• Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions
  • States that full test reports may not be required for 510(k) submissions but that a test summary may be adequate; PMAs require both 
  • Proposes a format for tabulated summaries for non-clinical bench performance test results to be used in conjunction with the narrative summaries
  • Contains the expected contents for summaries and full test reports

Product Specific Guidance

• Policy Clarification for Certain Fluoroscopic Equipment Requirements
  • JAA- system, x-ray, fluoroscopic, image-intensified
  • OWB- interventional fluoroscopic x-ray system
  • OXO- image-intensified fluoroscopic x-ray system, mobile

• Laser Products – Conformance with IEC 60825 and IEC 60601-2-22
  • Recognizes that FDA regulations are not in alignment with international standards and allows some potential variances from FDA regulations if following international standards

• Medical X-Ray Imaging Devices Conformance with IEC Standards
  • Encourages use of IEC standards to demonstrate compliance to Electronic Product Radiation Control requirements

• Utilizing Animal Studies to Evaluate Organ Preservation Devices
  • Outlines general considerations for the use of animal studies with these specific devices including ex vivo and in vivo models

Sometimes the short synopsis works, but sometimes you need to get to the details.

To fully understand how the EU MDR impacts you, check out our Understanding EU MDR and the Roadmap to Compliance webinar.

If you're looking for something even more advanced and to see how our experts are taking the regulations and putting them into practice, see our Integrating CERs and Post-Market Surveillance webinar.