Q&A: EU MDR Audits: Preparing, Managing & Responding to Nonconformances

R&Q's March 2020 webinar focused on dealing with EU MDR Audit Nonconformances. In this blog post, our knowledgeable EU MDR experts sat down to provide answers to your questions from the webinar and we hope that they will shed some light on similar questions that you may have on the topic. This is only a small sample of the questions that manufacturers currently have around EU MDR audits - and there are sure to be countless others!

R&Q is here to help address any other questions that you may have regarding audits or any other EU MDR related topics. Contact us today to find out how we can help!

If you were not able to attend this webinar, here's a link where you can sign up to view the on-demand version (and download the slides).
Q: What is still needed for EUDAMED, even if EUDAMED is delayed by two years? Can you list the certain elements that still apply from EUDAMED for the MDR implementation in May 2020? 

A: Manufacturers must have in place procedures for:
* Postmarket surveillance (PMS)
* Market surveillance
* Vigilance
* Registration of economic operators and devices

Q: Slide 18 states: "sampled per device category". What is a device "category" - is it per GMDN code, by "device codes", for example MDS, MDN, or some other definition?

A: While the MDR does not specifically define Device Category, the category of devices should be understood to be the relevant MDA/MDN codes (MDR), per Regulation (EU) 2017/2185 on the codes for the designation of notified bodies. Sampling by device category would be applicable to Class IIa devices.

Additionally, sampling per Generic Device Group should be applied to Class IIb devices. Generic Device Group is defined in the MDR as a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics. With respect to the MDR, the preferred nomenclature for Generic Device Group is the 4th level of the European Nomenclature on Medical Devices (EMDN) (i.e. combination of one letter plus six digits).

Q: Would account representatives, field support techs, or customer support representatives fall under economic operators? If not, how would a manufacturer go about making that distinction?

A: The full definition of "Economic Operators" is in MDR Article 2.1(35) with definitions of the various entities in Articles: 2.1(30), (32), (33), and (34), respectively.

Q: Is it required to have manufacturing process qualifications from a supplier for Class I Sterile accessory?

A: Generally, yes, and in particular for critical/special processes such as sterilization. [refs: MDR Annex II, para 6]

Q: Are auditors comfortable viewing QMS procedures and other documentation electronically or must that all be printed out?

A: This is auditor specific and should be determined ahead of an audit being conducted. The key here is for the procedures to be available in a clear, organized, readily searchable, and unambiguous manner.

Q: What examples have you seen for the format of Tech Documentation that meets the readily searchable concept? For example, by software, or by a single document with a list of other documents?

A: A bit of both methods have been utilized. The key here is to opt for a method that will be most effective for your size of document and what will work best with your current documentation control system used by your organization.

Q: Regarding MDR Declarations of Conformity, what is the relevant Union legislation expected to be listed on the certificate?

A: This is REGULATION which unlike the Directives will NOT be transposed into national laws. As such, the requirement is for a statement that the device complies with this regulation [EU 2017/745] and if applicable, with other relevant union legislation that make provision for issuing of a Declaration of Conformity.

Q: If CE certificates underwent early renewal and now expire in 2024, when should a company plan for the MDR audit? At what point should the application be completed?

A: Regardless of a MDR delay, MDR applications should be submitted to your Notified Body (NB) ASAP to allow for a timely review, advisement of an audit date, conduction of the audit, response to any audit findings and issuance of MDR certificate before May 2024.

Q: We are seeing some crazy price quotations from Notified Bodies - some of these appear to be truly excessive & unacceptable, in particularly for small device companies; is there any defined guidelines for NB in terms of cost management?

A: The only requirement is for NB pricing to be transparent.

Q: With MDR being delayed one year, what are the things companies need to do if products are being filed in Q1 of 2020?

A: Given current lead times for NBs to complete reviews and issue certificates, it is advisable to continue with MDR transition arrangements/work to ensure all your products are MDR compliant by May 2024.

Q: How long is it taking to secure a Notified Body for a biopharma?

A: This is subject to negotiation, as generally NBs are currently very selective about taking on any new clients.

Q: Are Class I devices not being audited?

A: Until May 2024, NB Conformity Assessments will be limited to only the sterility or metrological aspects (as applicable) of Class I devices (per MDD).

Q: How does one register with the Competent Authority (CA) as a Manufacturer? I have been trying to get this info, as well as the EUDAMED registration info.

A: If you are located outside of the European Union, please reach out to the CA of the Member state where your Authorized Representative resides, as listed on the EU Commission website.

Q: Can you talk about new symbols? Where they are placed and how symbol tables should document the new symbols?

A: ISO 15223:2016 addresses symbols to be used. It is currently being revised and, if there are no further major delays, is anticipated to be published as ISO 15223:2020 in Q4 2020.

Q: Maybe you can have a webinar on just labeling going forward?

A: We have one! Check it out here.

Q: Are EU MDR audits done alone or can they be done with MDSAP or ISO audits?

A: EU MDR audits can be conducted in conjunction with MDSAP and ISO 13485 audits by arrangement with your Notified Body. However, the paper trail for each audit type must be separate due to different rules governing the various certifications.

Q: Can you provide more details on what is needed when you apply for an EU MDR technical documentation review? Must an EU MDR audit be done first? Do you have to apply for this audit before you can apply for a technical documentation review?

A: The Regulations establish the need for the Notified Body (NB) to assess technical documentation for several devices, prior to issuing the Quality Management Systems (QMS) Certificate. For Class IIb, the Technical Documentation of at least one representative device per generic device group. This means that the NB should assess how many generic device groups are covered in the application.

For Class IIa, the technical documentation of at least one representative device per category of devices. This means that the Notified Body should asses how many categories of devices are covered by the manufacturer’s application.