Conformity Assessment Routes Under MDR 2017/745

As part of our ongoing look at the changes being brought about by MDR, we look at Conformity Assessment routes.  We look at changes under MDR and the assessment routes for different device classifications.

Update: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application.  The date of MDR application has moved to May 26th, 2021.  Articles that were written prior to the delay referenced the earlier date.  However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration.  Read more here.

Increase in Requirements

Conformity Assessment assessment routes under MDR 2017/745 have not significantly changed under MDR 2017/745 compared to MDD 93/42/EEC however, the timeline to CE marking might now be longer, particularly if there is involvement of expert bodies e.g the MDCG (Medical device co-ordination group).

The number of requirements of GSPR’s (Annex I- General Safety and Performance requirements) has increased under MDR compared to the number of Essential Requirements under MDD. Common specifications requirements have also been introduced for some devices.

Medical Devices are required to be in compliance with the relevant GSPRS (Annex I). Compliance with EN harmonised standards and Common specifications (CS) presumes compliance with the GSPR’s.

Summary of Conformity assessment routes under MDR 2017/745:

Class I

For Class I devices (with the exception of Class Im (measuring), Class Is (sterile) and Class Ir (reusable)), the ‘self-certification’ route is acceptable with a requirement to maintain Technical documentation according to Annex II and Annex III.

However, for Class Im, Class Is and Class Ir, a limited QMS (Quality Management system) must be in place to control the production (Annex XI Part A) or to control the special characteristics (Annex IX Chapter I). The involvement of an NB (Notified Body) is required to assess this QMS

Class IIa

Class IIa devices may undergo conformity assessment under Annex IX (Full QMS) or undergo assessment under Annex XI (Production Control) together with Technical documentation as per Annex II and III.

Conformity assessment under Annex IX (Full QMS) requires an NB audit of QMS and NB assessment of the Technical Documentation/Design Dossier.

Conformity assessment under Annex IX requires an NB audit of Production Quality Assurance for the ability to produce and test the device.

Class IIb

Class IIb devices categories are

  • Class IIb implantable
  • Class IIb active device intended to remove or administer medicinal substances
  • Class IIb devices not included as any of the above.

For Class IIb devices, that are not active or intended to remove or administer a medicinal substance, conformity assessment via either of the following routes may be considered.

  • Class IIb implantable – Annex IX Chapter I (QMS) and Section 4 (Technical documentation for every device without expert review)
  • Class IIb non-implantable – Annex IX Chapter I (QMS) and Section 4 (Technical documentation for representative device without expert review)

Or

  • Annex X (Assessment based on Type-Examination) and Annex XI-Part A (Production Quality Assurance)

Or

  • Annex X (Assessment based on Type-Examination) and Annex XI-Part B (Product verification)

For Class IIb devices that are active and intended to administer or remove a medicinal product, the following conformity assessment routes may be used:

  • Annex IX Chapter I (QMS) and Section 4 (Technical documentation for every device with expert review)

Or

  • Annex X (Assessment based on Type-Examination) and Annex XI-Part A (Production Quality Assurance)

Or

  • Annex X (Assessment based on Type-Examination) and Annex XI-Part B (Product verification)

Class III

For Class III devices the following Conformity assessment routes may be used:

  • Annex IX (Assessment based on a QMS and assessment of full Technical documentation)

An expert panel will also be required to evaluate Class III implantable devices

Or

  • Annex X (Assessment based on Type-Examination) and Annex XI-Part A (Production Quality Assurance)

Or

Annex X (Assessment based on Type-Examination) and Annex XI-Part B (Product verification)

There are additional requirements in Annex IX for devices incorporating medicinal product, devices incorporating animal or human tissues/cells or for devices introduced into the human body through bodily orifices or applied on the skin and intended to be absorbed or local dispersed.

EUDAMED

Under MDR, CE mark Certificates will be required to be registered in EUDAMED (European Electronic database). This database will be accessible by the EU Commission, Competent Authorities and the MDGC.

Conclusion

Conformity assessment routes under MDR have not significantly changed since MDD however, timelines for CE marking may be increased due to additional scrutiny by Competent Authorities or expert panels via the EU Commission or the MDGC.

Also, there are also additional requirements for the GSPR’s under MDR compared to the Essential Requirements of the MDD.

Some devices may be required to be reclassified under the list of classification rules that have now changed under MDR.

The impact of MDR not only impacts Medical Device manufacturers but also Competent Authorities, Notified bodies as well as the Economic operators involved with the device.

We Can Help

Our MDR team is dealing with many clients and helping them to prepare for the impending deadline.  Talk to us today by calling 00353 52 61 76 706 or complete the form below.

Further Reading on MDR

A Guide to Drug Device Combination Products

We have produced a drug device guide that looks at the issue.  It also considers the issue in relation to the changes for drug device combination products in relation to the Medical Device Regulations.  You can download the guide here.

The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR

As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC).

The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read more here.

Get The 1st Acorn Regulatory Medical Device Regulations Whitepaper

The new medical device regulations (MDR) will come into force in May 2020.  In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations.  For many companies, there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Read the first whitepaper here

2nd Acorn Regulatory MDR Whitepaper

Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR and post-market surveillance. Read the second MDR whitepaper here.

The Medical Device Regulations – MDR – What You Need To Know

The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover from the MDD to MDR. During our interactions with these clients, many topics are being raised time and again. Read more here.

About the Author
Orla Keane
Medical Devices Manager
An engineer by background, she has 15 years experience in medical devices. Prior to joining Acorn Regulatory, she spent over 12 years at the HPRA in various roles within the medical devices team. She was responsible for a team within post market surveillance and vigilance across various general and active implantable medical device product families. Orla also served as co-Chair of the Compliance and Enforcement working group in Brussels for many years. She has previous industry experience at an orthopaedic implant manufacturer. Orla currently assists Acorn Regulatory clients in a variety of areas including regulatory strategy, EU authorised representative support and preparation for MDR, particularly on the topic of post market surveillance.
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Bronwyn Kelly
Senior Regulatory Affairs Advisor - Medical Devices
Bronwyn Kelly is a Senior Regulatory Affairs Advisor in our growing medical devices team. She has a wealth of experience in both device and pharmaceutical regulatory affairs and she has worked with some of the world's biggest companies in both sectors, In her current role she works with device clients on issues such as EU Authorised Representative and PRRC (Person Responsible for Regulatory Compliance) related issues.
Email Bronwyn