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Proposed IVDR Transitional Provisions Amendment

The European Commission published a formal proposed amendment [COM(2021)627] to the In Vitro Diagnostic medical devices Regulation (EU) 2017/746 (IVDR) on 14 October 2021 which specifically updates the transitional provisions in Article 110. This is good news for IVD manufacturers, who have long been hoping for additional time in order to meet the new requirements and obligations of the Regulations. This will need to be put forward for a formal vote and will be applicable after it has been published in the Journal of the European Union.

The proposal provides a lengthy explanation for the extension. Whilst stating that the COVID-19 pandemic has confirmed the need for a robust regulatory framework for in vitro diagnostic medical devices in the EU, it is also had a negative impact on the implementation of the IVDR. A shift in priorities and travel restrictions impeded the progress of the Commission and other stakeholders in the EU, thus leading to a general unpreparedness for the IVDR’s original date of application, 26 May 2022.

The Commission estimated that conformity assessment procedures could take up to a year to complete, after which it would take on average 6 months to produce the IVDs and place on the market. With only a handful of Notified Bodies designated towards the IVDR, and given the fact that an estimated 80% of IVD medical devices will require Notified Body intervention under the Regulation, the industry has long been calling for an extension. Enforcing the 26 May 2022 deadline would no doubt culminate in a perfect storm of IVD shortages on the market, having a disastrous effect on the healthcare industry and patient wellbeing.

It is being proposed that Article 110(2) be amended such that certificates issued in accordance with the IVD Directive 98/79/EC (IVDD) shall become void at the latest on 27 May 2025, giving these a one-year extension. Paragraph 3 of Article 110 will be replaced by the following:

(3) By way of derogation from Article 5 of this Regulation, the devices referred to in the second and third subparagraphs of this paragraph may be placed on the market or put into service until the dates set out in those subparagraphs, provided that from the date of application of this Regulation they continue to comply with Directive 98/79/EC and provided that there are no significant changes in the design and intended purpose.

Devices with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of paragraph 2 of this Article may be placed on the market or put into service until 26 May 2025.

Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until the following dates:

(a) 26 May 2025 for class D devices;

(b) 26 May 2026 for class C devices;

(c) 26 May 2027 for class B devices;

(d) 26 May 2027 for class A devices placed on the market in sterile condition.

However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to devices referred to in the first, second and third subparagraph instead of the corresponding requirements in Directive 98/79/EC.

In summary, an IVD medical device compliant with the IVDD and holding a Notified Body certificate, will have till the end of the validity period of that certificate, and can be placed on the market or put into service until 26 May 2025.

For devices which did not require a Notified Body under the IVDD (as in the case of ‘General IVDs’) and whose conformity assessment procedure under the IVDR will now require Notified Body intervention, the transition period has been staggered depending on their risk classification.

Paragraph 4 of Article 110 has also been amended and gives further provisions for when IVDD-compliant devices may remain on the market or put into service.

(4) Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025.

Devices lawfully placed on the market from 26 May 2022 pursuant to paragraph 3 of this Article may continue to be made available on the market or put into service until the following dates:

(a) 26 May 2026 for devices referred to in paragraph 3, second subparagraph, or in paragraph 3, third subparagraph, point (a);

(b) 26 May 2027 for devices referred to in paragraph 3, third subparagraph, point (b);

(c) 26 May 2028 for devices referred to in paragraph 3, third subparagraph, points (c) and (d).’;

We recommend reviewing the below definitions from the IVDR to fully understand the above:

‘making available on the market’ means any supply of a device, other than a device for performance study, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

‘placing on the market’ means the first making available of a device, other than a device for performance study, on the Union market;

What constitutes a significant change? The EU’s Medical Device Coordination Group (MDCG) released guidance document ‘MDCG 2020-3’ which explains in some detail what is considered to be a significant change in relation to the Medical Device Regulation (EU) 2017/745 (MDR) Article 120(3). This may be extrapolated for use to explain significant changes in relation to IVDs. The MDCG guidance provides a series of flowcharts which may be followed to determine whether the change to design or intended purpose would be considered significant or not. Such changes should always be discussed on a case-by-case basis with the relevant Notified Body, however, the following changes would not be deemed significant:

  • Reductions or limitations of the intended purpose.
  • Design changes related to corrective actions assessed and accepted by the Competent Authority.

MDCG 2020-3

Importantly, IVDs which did not require Notified Body intervention under the IVD Directive and which will be classified as Class A under the IVDR will need to transition to the IVD Regulation by 26 May 2022 in order to place these on the market after that date. This also applies to ‘new IVDs’ which do not have a Declaration of Conformity or valid certificate dated prior to 26 May 2022. We encourage all manufacturers of Class A non-sterile devices to meet the requirements as soon as possible to avoid issues in placing your products on the market.

For manufacturers who will benefit from the extended transition period introduced by Article 110(3), you will still need to comply with certain sections of the IVDR, as specified above. The following technical documentation updates will be required as a minimum:

  • Updating the Post-Market Surveillance (PMS) Plan in accordance with Annex III.
  • Developing a PMS Report or a Periodic Safety Update Report (PSUR).
  • Updating existing procedures on vigilance to meet the requirements in Chapter VII Section 2. Of note is that ‘other’ adverse events shall be reported within 15 days rather than 30 days under the previous Directives.

These changes must be implemented within the technical documentation and QMS from 26 May 2022.

The following amendments to the IVDR will also be made:

  • Article 112, second subparagraph, the date ‘27 May 2025’ is replaced by ‘26 May 2028’.
  • Article 113(3), the following points (i) and (j) are added: ‘(i) Article 5(5), points (b), (c) and (e) to (i), shall apply from 26 May 2024; (j) Article 5(5), point (d), shall apply from 26 May 2028.’.

The latter points in Article 113(3) (i) and (j) will be positive for those devices being manufactured and used only within health institutions, effectively providing an extended grace period and more breathing room for them to meet the obligations of Article 5(5) of the IVDR.

Proposed IVDR Amendment COM(2021)627

How can Advena help you?

Advena has well over 20 years of professional experience within the medical device industry as both a leading EU Authorised Representative and regulatory consultants. We are able to guide you through the complexities of EU regulation and help you place compliant devices on the market:

  • Regulation Gap Analysis for Directive-compliant technical documentation and QMS.
  • Regulation-compliant technical documentation.
  • Regulation-compliant QMS.
  • EU Authorised Representative service under the EU Regulations.

EN ISO 13485:2016 Amendment

The much anticipated amendment to EN ISO 13485:2016 has now been published in the form of A11:2021, providing manufacturers with updated Annexes ZA and ZB to reflect the obligations and requirements of the new EU Regulations for medical devices and IVDs.

The EU Regulations clearly stipulate that all medical device manufacturers shall have a Quality Management System (QMS) in line with the Article 10 obligations within the Regulations. Devices requiring Notified Body intervention will also need to meet QMS requirements within their appropriate conformity assessment procedures, as laid out in Annex IX or Annex XI. Once the standard is cited within the Official Journal of the European Union for that Regulation, compliance with the normative references given in Annexes ZA and ZB of the standard, presumption of conformity with the corresponding Regulation and EFTA Regulations may be conferred.

EN ISO 13485:2016+A11:2021 compares the QMS requirements of Article 10 and Annexes IX and XI with the corresponding requirements of the ISO 13485:2016 standard, providing notes on whether these are covered by the standard or not. One could thus follow these notes in order to identify those areas of their QMS which will need to be updated with respect to the EU Regulations.

We would recommend that all manufacturers who are using an ISO 13485 compliant QMS to purchase this amendment and go through Annexes ZA or ZB as appropriate in order to determine which elements of the QMS will need to be revised in order to comply with the requirements of the MDR or IVDR.

Advena can conduct a comprehensive gap analysis on your existing QMS documentation in order to highlight any deficiencies with respect to the EU Regulations and ensure your system is compliant. Our Gap Analysis Reports also provide recommendations on how these gaps may be resolved as well as tips on how to improve your QMS.

MDR Article 120 – Transitional Provisions

On 26 May 2021, the Medical Device Regulation (EU) 2017/745 (MDR) began to apply following a 4-year transition period from the previous Active Implantable Medical Device Directive 90/385/EEC (AIMDD) and Medical Device Directive 93/42/EEC (MDD).

The ‘Transitional Provisions’ within Article 120 of the MDR govern this switch and lay out specific derogations from the Regulation which has had a great impact on how and when medical device manufacturers transition. In fact, many manufacturers have been able to benefit from these derogations, allowing them more time to meet the requirements of the MDR.

Paragraph 2 of Article 120 focusses on the validity of certificates issued in accordance with the MDD and AIMDD prior to 25 May 2017. Certificates which have been issued before this data will remain valid until the end of their validity period, with the exception of those certificates issued in accordance with Annex 4 of the AIMDD or Annex IV of the MDD, which become void 27 May 2022. Furthermore, the validity date for AIMDD and MDD certificates issued after 25 May 2017 shall not exceed 27 May 2024. The Notified Body who has issued the AIMDD or MDD certificate will continue to be responsible for the surveillance relating to those medical devices.

 

Article 120 paragraph 3 lays out the key derogations to MDR, it states:

By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May [2021] and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May [2021] it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.

 

There are several implications of this paragraph which shall be broken down below.

If a device which has been classified as class I under the MDD will now require Notified Body intervention under the new classification rules of the MDR (annex VIII), the manufacturer shall have until 26 May 2024 to meet the new requirements, provided that its MDD Declaration of Conformity was drawn up prior to 26 May 2021. Reusable surgical instruments and software are typical examples of devices which have been classified as class I under the MDD and which will now require the involvement of a Notified Body and which may benefit from the extended transitional period introduced by Article 120(3). The definition of a reusable surgical instrument is provided in Annex VIII Chapter I Section 2.3.

However, as with most good things, certain terms and conditions will apply:

  1. The device must continue to comply with the Directives from 26 May 2021.
  2. There can be no significant changes to the device design or intended purpose from 26 May 2021.
  3. The MDR requirements within the following sections shall apply from 26 May 2021:
    1. Post-Market Surveillance [Article 83-86, 92, Annex III].
    2. Market Surveillance [Article 93-100].
    3. Vigilance [Article 87-92].
    4. Registration of economic operators and devices [Article 31 and 29].

What constitutes a significant change? The EU’s Medical Device Coordination Group (MDCG) released guidance document ‘MDCG 2020-3’ which explains in some detail what is considered to be a significant change in relation to Article 120(3). The MDCG guidance provides a series of flowcharts which may be followed to determine whether the change to design or intended purpose would be considered significant or not. Such changes should always be discussed on a case-by-case basis with the relevant Notified Body, however, the following changes would not be deemed significant:

  • Reductions or limitations of the intended purpose.
  • Design changes related to corrective actions assessed and accepted by the Competent Authority.

MDCG 2020-3

 

As a result of Article 120(3), medical devices classified as class I under the EU MDD and which will be classified as class I under the EU MDR and which are not covered by a valid CE certificate (e.g. sterile or measuring class I devices) will need to meet the requirements and obligations of the MDR from 26 May 2021. This implies that ‘simple’ class I device manufacturers will not be able to place their MDD-compliant medical devices on the EU market until they have satisfied the requirements of the MDR.

 

For manufacturers who are benefitting from the extended transition period introduced by Article 120(3), you will still need to comply with certain sections of the MDR, as specified above. The following technical documentation updates will be required as a minimum:

  • Updating the Post-Market Surveillance (PMS) Plan in accordance with Annex III.
  • Developing a PMS Report or a Periodic Safety Update Report (PSUR).
  • Updating existing procedures on vigilance to meet the requirements in Chapter VII Section 2. Of note is that ‘other’ adverse events shall be reported within 15 days rather than 30 days under the previous Directives.

These changes must be implemented within the technical documentation and QMS from 26 May 2021.

 

Article 120(3) also implies that all manufacturers placing medical devices on the EU market for the first time, will need to immediately meet the requirements and obligations as laid out in the EU MDR for their medical device.

 

How can Advena help you?

Advena has over 20 years of professional experience within the medical device industry as both a leading EU Authorised Representative and regulatory consultants. We are able to guide you through the complexities of EU regulation and help you place compliant devices on the market:

  • Regulation Gap Analysis for Directive-compliant technical documentation and QMS.
  • Regulation-compliant technical documentation.
  • Regulation-compliant QMS.
  • EU Authorised Representative service under the EU Regulations.

New Vacancies at Advena UK

We are excited to announce, that  Advena UK are expanding!

We are looking to recruit two highly experienced regulatory professionals to join the UK team.

Our role is to support small/medium sized medical device manufacturers, & start-up organisations to achieve EU/UK/US regulatory compliance.

The positions currently are:

Medical Device Regulatory Consultant/Specialist (IVD/IVDR)

Salary: £45-£70k depending on experience

Job specification link: Advena Ltd UK V02 IVDR

Medical Device Quality and Regulatory Consultant (MDD/MDR)

Salary: £45-£55k depending on experience

Job specification link: MDD Vacancy

 

 

Please email me to discuss the opportunities available.

Kind regards,

Helen George

Business & Project Manager, UK

Published: July, 2021

 

 

 

Due to Continued Growth, Advena Limited in Malta are Looking for a Regulatory Intern.

Due to our continued expansion in Malta, Advena Limited are seeking to add a Regulatory Intern to our team of regulatory specialists, this is an exciting opportunity for an individual who has an interest in medical devices and new medical technology, we offer ‘on the job’ training to the successful applicant who over time would progress to Regulatory Associate as a steppingstone into consultancy.

We invite applications from students in their final year or those who have recently graduated.

Initial Responsibilities:

  • Gain an understanding of Regulation (EU) 2017/745 & (EU) 2017/746.
  • Basic technical documentation reviews.
  • Regulatory administration.
  • Scheduling.
  • Research.
  • Liaising with external regulatory authorities to ensure approvals are obtained in line with project schedules.
  • Performing all activities in compliance with relevant Quality Systems standards and specifically with ISO 13485.

Applications should be majoring in Engineering or comparable/similar disciplines.

Role Title:

Regulatory Intern – Medical Devices

Schedule:

Full-time.

Location:

Office Based in Swatar, Malta

About Us:

Advena Limited is essentially two companies; Advena Limited in the UK and Advena Limited in Malta. Both companies are expanding medical device consultancy business, the UK business primarily has a client base from within the EU (including the UK), while our office in Malta has a client base who are located outside the EU. As a group we specialise in supporting small to medium sized medical device manufacturers and start-ups, to achieve regulatory compliance and CE Mark their medical device products.

In Summary

This is an exciting time to join Advena, in this entry level role that has plenty of potential, within our small team of regulatory specialists, to primarily work on assisting with the preparation of technical documentation and files for submission for audit by Notified Bodies. However, there are also business administration duties, including our quality management system, that must be carried out that underpin our activities.

As Regulatory Intern, you will be an integral member of our team, you will be guided by senior team members, providing you with the requisite support and guidance, enabling you to gain valuable experience to grow and develop with Advena.

Applications

If you have a keen interest in technical documentation and in medical devices and would be interested in a career in Regulatory Compliance, with the long-term goal of becoming a consultant and can demonstrate an understanding of the criteria outlined here, we would love to hear from you.

Applications must be submitted to Mr Anthony Kirby by email to anthony.kirby@advenamedical.com including a copy of your CV. by 30th June 2021, for those selected for an initial interview, these are currently planned to be held mid-July.

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