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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.

Quality Management Systems (QMS) Under the MDR

Regulation (EU) 2017/745 (MDR) requires manufacturers of devices, other than investigational devices, to establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and such that it is proportionate to the risk class and the type of device. Article 10 (9) of the MDR goes into further detail.

Manufacturers should be looking closely at their QMS to ensure it meets the requirements of the Regulation. A QMS to ISO 13485:2016 will cover most of these aspects, but not all. Therefore, it will be vitally important to carry out a review of your QMS.

The implementation of the MDR to 26th May 2021 is not far away, so please use this time wisely.

If you don’t have the resources internally or locally, remember Advena have a team of consultants who can help and should you need our assistance please do contact us and we will happily discuss and provide you with a quotation to review your QMS. If you need to implement a new QMS, we can also quote for this.

Email us at: Info@advenamedical.com

COVID-19| Protective Equipment

Most of the equipment being used as protection against airborne particles and small droplets are covered by specific EU harmonised legislation. The vast majority of these products are classified as Personal Protective Equipment (PPE) and fall under the scope of Regulation (EU) 2016/425. These products are intended to protect the wearer.

Products that are intended to protect the patient, such as medical gloves and medical face masks, will fall under the scope of the Medical Device Directive 93/42/EEC (MDD) (to be replaced by the Medical Device Regulation 2017/745 (MDR)).

Meeting either of the above legislation will allow the manufacturer to legally affix the CE mark and circulate freely in the EU. The essential requirements of the PPE Regulation and the MDD may be met by following harmonised standards, which are published in the Official Journal of the European Union. Following this technical solution, conformity to the essential requirements may be presumed.

The following harmonised standards are applicable to face masks:

FFP-Type [PPE]             EN 149:2001+A1:2009

Medical [MD]                EN 14683:2019+AC:2019

These standards may be obtained through the following link.

The manufacturer is not required to meet all the specifications of these standards and can adopt different technical solutions. However, due to the presumption of conformity, time-to-market may be reduced drastically.

The manufacturer may decide to carry out the tests prescribed in the harmonised standards themselves or outsource this testing to a laboratory. Should the manufacturer follow these standards, the EU Competent Authorities may take a product sample and test these in accordance with the tests prescribed in the standard as part of market surveillance procedures.

Additional technical solutions and guidelines have been compiled in a list by the World Health Organisation. However, in following one of these alternative standards referred to by the WHO for PPE products, the manufacturer shall submit a sample to be tested by a designated notified body. The EU Commission has urged notified bodies to prioritise new requests for COVID-19 related PPE. In a Recommendation issued on 13 March 2020, the Commission encourages notified bodies to adopt derogations which will allow speedier market access under certain conditions.

  • Point 7 of the Recommendation allows manufacturers to anticipate the placement of their products on the market whilst the conformity assessment procedures are being finalised.
  • Point 8 of the Recommendation allows manufacturers to place their products on the market even if no conformity assessment procedures have been initiated.

Under the MDD and the MDR, medical face masks and examination gloves are considered to be class I medical devices, and as such are dependent on self-assessment and will not require notified body intervention. However, if provided in a sterile state, a notified body will be required to assess those aspects of sterility.

On the other hand, face masks and equipment used to protect against COVID-19 and are covered by the PPE Regulation are classified as Category III PPE, and thus a notified body must be involved.

In both cases, PPE and medical devices must be placed on the market with the EU/EC Declaration of Conformity document, as well as the accompanying CE Certificate issued by the notified body, when applicable. No other documents are required for market access, however, there are some additional considerations to keep in mind.

Issuing a Declaration of Conformity (DoC) signifies that you comply with that specific EU Regulation / Directive and that you have met all their requirements. Part of these requirements will be to develop and maintain a set of technical documentation.

Medical devices falling into class I, must be registered with the applicable EU Competent Authority in the country in which the manufacturer or their EU Authorised Representative is based.

For more information on how to lawfully place your PPE or medical devices on the EU market, please do not hesitate to contact us at info@advenamedical.com.

MDR ARTICLE 120(3) TERMS AND CONDITIONS

It would seem like there will be a considerable number of medical devices compliant with the MDD on the market after 26 May 2020. To compensate, the Article 120(3) of the MDR requires that such devices opting for this ‘legacy route’ meet certain conditions:

From 26 May 2020:

  • The device continues to comply with the Directive.
  • There are no significant* changes in the design or intended purpose.

Furthermore, the requirements in the MDR related to the following shall apply:

  • Post-Market Surveillance [Article 83-86, 92, Annex III]
  • Market Surveillance [Article 93-100]
  • [Article 87-92]
  • Registration of economic operators and devices [Article 31 and 29]

* The MDCG have produced guidance on significant changes, please see this link.

Whether a change in design or intended purpose may be considered as significant shall be determined on a case by case basis, however, the following changes shall not be considered to be significant:

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

The Notified Body who has issued the AIMDD/MDD certificate shall continue to be responsible for the surveillance relating to the devices it has certified.

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