July 7, 2021 Regulatory Updates
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Medical Devices USA/Europe Regulatory Updates round up – June 2021

EUROPE

1. Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorized representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR

This Q&A is a document aimed at addressing questions relating to the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 of Regulation (EU) 2017/745 on medical devices (MDR) and/or Article 28 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It also clarifies the cases where an Actor ID is issued instead of an SRN.

1.   What is the procedure to register as actor in EUDAMED?
2.   Do manufacturers of only custom-made devices have to register as actors in EUDAMED?
3.   When do manufacturers of only custom-made devices4have to register as actors in EUDAMED?
4.   Do manufacturers of only legacy devices have to register as actors in EUDAMED?
5.   Do manufacturers of only ‘old’ devices have to register as actors in EUDAMED?
6.   Do system and procedure pack producers (SPPP) have to register as actors in EUDAMED?
7.   Who is the authority responsible for the approval of actor registration requests of SPPP located in non-EU countries?
8.   When the Actor ID may be considered as a Single Registration Number (SRN) pursuant to Article 31 MDR and Article 28 IVDR?

2. The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices

The MDCG hereby endorses the principles laid out under Appendixes E – I of the IMDRF N48 guidance document, as published on 21March2019 on the IMDRF website.

For ease of readability, this document intends to provide clarifications as to how certain principles and examples outlined in N48 Appendixes E-I apply under the MDR/IVDR. The examples provided with in the Appendixes are for informative purposes and should not be interpreted as the sole manner for complying with UDI obligations.

It is recommended that these documents are always read in conjunction with Regulation (EU)2017/745 on medical devices (MDR) and Regulation (EU)2017/746 on in vitro diagnostic medical devices (IVDR) and to take into consideration the respective issuing entity rules.

Certain principles and terminology set out with in the IMDRF N48 Appendices are not applicable under the MDR/IVDR. The following comparison table explains the applicable MDR/IVDR principles and terminology that should be applied for compliance and is non-exhaustive in its nature. Please note that ‘X’ in the table below indicates that this IMDRF principle/terminology is not applicable under either the MDR and/or IVDR.

3. Clinical investigation application/FAQ on the European Medical Device Nomenclature (EMDN)

FAQ on the European Medical Device Nomenclature (EMDN)

1.   What is the European Medical Device Nomenclature (EMDN)?
2.   How was the EMDN created?
3.   What are the key principles of EMDN?
4.   How do I gain access to the EMDN?
5.   How is the EMDN structured?
6.   Which level of the EMDN should I use to assign a term to my device?

For More Information check below link

4. New Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the IVDR

7.   A new legislative framework on medical devices, comprising Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)2 was adopted by the Council and the European Parliament in April 2017. This new framework sets high standards of quality and safety for medical devices and aims at ensuring the smooth functioning of the internal market. The MDR was envisaged to apply from 26 May 20203. In contrast, the IVDR has a date of application of 26 May 2022. In March 2020, the Medical Device Coordination Group (MDCG), composed of experts appointed by Member States, endorsed a joint implementation plan on the implementation of the MDR. The plan listed priority actions for the Member States and Commission services, to be monitored at the level of the MDCG. The MDR joint implementation plan recognized the need to carry out a similar exercise for the IVDR. The present document therefore proposes a draft joint implementation plan for the IVDR.

5. Guidance on Implant Card–‘Device types’

Implant Card–‘Device types’

Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) Version1.1

According to Article 18 (a) of the MDR, the manufacturer of an implantable medical device shall provide together with the device, information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer.

In accordance with the instructions laid out in MDCG 2019-8, the implant card should also indicate a ‘device type’ for the implantable medical device in question.

As such, this document provides a non-exhaustive list of implantable medical ‘device types’ in order to aid manufacturers in allocating an appropriate term for this requested information.

A balance between the information a patient and a healthcare professional require was a main driver behind the suggested ‘device types’.

This document will be updated, as appropriate, and following the agreement of the MDCG.

6. European Medical Device Nomenclature (EMDN) – Questions and Answers

Following Questions are answered as follows:

8.   What is the European Medical Device Nomenclature?
9.   How was the EMDN created?
10.   What are the key principles of the EMDN?
11.   How do I gain access to the EMDN?
12.   How is the EMDN structured?
13.   Which level of the EMDN should I use to assign a term to my device?

US FDA

7. Unified Agenda: FDA In Brief: FDA Announces Qualification of a Medical Device Development Tool to Help Assess Patient- Reported Outcomes with LASIK Surgery

“LASIK is a surgical procedure intended to reduce a person’s dependency on glasses or contact lenses. Patient-reported outcomes, such as visual symptoms and satisfaction with vision, are vital to understanding the potential outcomes that that can result from LASIK. The FDA has used medical device development tools to help us reach regulatory decisions and include these important patient-reported outcomes.

Patient-Reported Outcomes with LASIK Symptoms and Satisfaction also known as PROWL-SS has been qualified as a scientifically validated tool to assess individuals’ symptoms and satisfaction with vision associated with LASIK surgery.

This tool will support the FDA’s premarket and post-market regulatory decision making and can be used by manufacturers for the development and evaluation of LASIK devices.

PROWL-SS provides patients, eye-care providers and manufacturers with valuable information about important patient-reported outcomes.”

8. Draft:Remanufacturing of Medical Devices

Medical devices encompass a vast array of products with different technologies, product lifecycles, complexity, intended users, and environments of use. Many devices are reusable and need preventive maintenance and repair during their useful life. For these devices, proper servicing is critical to their continued safe and effective use. However, there is a lack of clarity regarding the distinction between “servicing” and “remanufacturing” of a device. Most notably, remanufacturing has implications for the regulatory responsibilities of entities performing these activities.

9. FDA releases first Cures Act report on patient experience data in regulatory decision-making

Assessment of the Use of Patient Experience Data in Regulatory Decision-Making
The US Food and Drug Administration (FDA) has published its first report on how it uses patient experience data in regulatory decision-making.

  • FDA reviewers sometimes seek patient experience data from PFDD meetings and Voice of the Patient reports, patient workshops and symposiums, patient testimony at Advisory Committee meetings, patient listening sessions, patient advocacy group meetings, clinical practice, and the medical device reporting system.

CANADA (HC)

10. Cancellation of MDELs for failure to pay fees

Medical Devices Compliance Program Bulletin

  • Fees for Medical Device Establishment Licences (MDELs)
  • Authority to withhold services in case of non-payment
  • Cancellation of existing MDELs
  • Resuming activities after MDEL cancellation
  • Contact us

11. Off-label advertising and sale of rapid antigen tests under workplace screening program: Interim Enforcement approach

Medical Devices Compliance Program Bulletin

The Medical Devices Compliance Program (MDCP) within the Regulatory Operations and Enforcement Branch (ROEB) oversees the national compliance and enforcement program for medical devices. MDCP manages the risk posed to public health and safety by medical devices in a number of ways:

  • compliance promotion activities
  • medical device establishment licensing
  • inspections
  • compliance, investigation and enforcement
  • reporting and mitigation of medical device shortages

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