Gap Analysis MDD-MDR transition

Gap Analysis MDD-MDR transition

In February 2023, the EU Commission extended the Notified Body (NB) certificates issued under the MDD (which would be otherwise valid until 26 May 2024 and possible to market on the EU until May 2025).
The extension is until the end of 2027 (for higher-risk devices such as class III and Class IIb implantable) and until the end of 2028 (for the mid and smaller-risk devices which are other class IIb, class IIa, class Im (with measuring function), class Is (sterile) and class Ir (reusable surgical instruments)).
Manufacturers of these medical devices must meet specific criteria such as MDR readiness and an MDR application at a notified body by 26 May 2024.
This extension is intended to give manufacturers more time to achieve compliance with MDR and to “buy” some time for Notified Bodies to process the applications that had amassed towards the end of the grace period.
However, the lowest risk Class I self-certified devices (which are not class Im, Is or Ir, (or up-classified under MDR) are not included in this extension nor were they included in the original extension (grace period) described under Article 120 of MDR.

Therefore, all Class I self-certified devices must fully comply with MDR from 26 May 2021.

26 May 2024	Lodge an application for conformity assessment (do not wait!) and MDR QMS in place (Significant changes procedure, Vigilance, Economic Operators (EUDAMED), Device registration and PMS as applicable). End of transition period for devices that don’t meet requirements.
26 September 2024	Sign a written agreement with Notified Body to benefit from the extended transitional period.
31 December 2027	Higher-risk devices – This includes Class III devices and Class IIb implantable devices, excluding sutures, braces, dental fillings & braces & crowns, screws, wedges, plates, wires, pins, clips and connectors.
31 December 2028	Medium and lower risk products – This includes other class IIb products, class IIa products and ls, lm, lr, and up-classified devices)

The legal manufacturer is responsible for ensuring that the product’s technical documentation (TD) is current and compliant with MDR requirements.
TD, which is prepared according to the Directives (MDD) must be updated. Likewise, you should use the most updated and harmonized applicable standards to demonstrate compliance. For example, Notified Bodies and EC REPs expect you to use ISO 14971:2019 to meet risk management requirements; the older 2012 version is no longer acceptable.
As an initial step, we would advise you to undertake a review or gap analysis of your existing technical documentation and compare it against the requirements of the regulation you wish to comply with.

Our experts have a skilled and experienced team of consultants who are ready and able to assist in providing you with a gap analysis service in a cost-effective manner.
Upon completion of the Gap Analysis, BioReg will prepare a comprehensive report highlighting any deficiencies or nonconformities against referenced requirements and providing suggestions for closing these gaps.
In addition, based on our report, we shall provide a quotation to bring your documentation in line with the requirements of the Regulation you wish to comply with.
Such a gap analysis can be applied to your whole technical file or to sections such as the Clinical Evaluation section or Risk Management section, or as you require.
Similarly, a gap analysis can be applied to your Quality Management System (QMS) mainly as there is now a strong link between QMS and the new Regulations.

A recent (17 May 2024) NB Survey on MDR/IVDR certifications and applications tells us that most MDR application refusals could be easily avoided as they are either administrative in nature – applications are not complete or due to incorrect product qualification and classifications – where our experienced team could help.

Frequently Asked Questions

Question: I searched for the UDIs for medical devices approved under MDR in Eudamed. Unfortunately, many products have no UDIs registered yet. Could you please explain what is the reason for this?

Answer: A Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of EUDAMED is published on 24 January 2024. The new proposal aims to enable the gradual implementation of individual EUDAMED modules once they have been audited and declared functional. This replaces a concept where EUDAMED is mandatory only after all modules (including Clinical investigations/Performance studies, which are delayed) become fully functional—which, according to this, would be required only in 2029. According to this new proposal, mandatory use of several modules could then start as early as Q4 2025. Meanwhile, they are voluntary.

Question: A quality service provider (not a manufacturer) for medical device manufacturers wrote that one of their customers was recently audited by a Notified Body (NB). NB told them that our ISO 13485:2016 certificate was invalid as it had not been issued by an NB. They explain that non-NB parties are unaware of MDD & MDR quality issues and, therefore, they don’t accept such certificates. Is the approach of NB correct?

Answer: No, such NB approach is not correct. We received similar complaints from our clients. NBs could be concerned about everything. However, such concern doesn’t give them the right to “invalidate” the ISO 13485 certificate issued by the non-NB accreditation body. If NB suspects that the non-NB party that issued the ISO 13485 certificate is unaware of MDR-related quality aspects, they should check them during their annual audit. After all, the manufacturer is expected to meet quality MDR expectations, and it can summarize them, e.g., in the Strategy for regulatory compliance procedure (as per Article 10, MDR), which may include the control of your service providers.

Question: Since accessories are also referred to as devices (Article 1:4), they are not excluded from the definition of “clinical benefit” in the MDR, and therefore, we thought, according to MDR, we need to assess “clinical benefit” for each accessory in our product. Is our approach correct?

Answer: We understand your logic; however, if you follow it to its full potential, you will have to do GSPR, PMS, PMCF, Risk, etc., for each accessory of the product, which was not, in our opinion, the legislator’s intention.   Each accessory contributes to the final product’s overall “clinical benefit,” benefit-risk ratio, etc. of the product, and we can describe such contributions in TD. Still, we would reserve the term “clinical benefit” for the final product only. I think that your approach may apply to a greater extent to the products contained in the “Procedure pack” (MDR 2(10) or “System” (MDR 2(11)). Similarly, for devices incorporating a medicinal product (Rule 14), you need to justify (clinical benefit, etc.) the addition of medicinal substance(s).

Question: Could my device be a candidate for Orphan Device status?

Answer:  As per  MDCG 2024-10 Clinical evaluation of orphan medical devices, an “orphan device” (or OD) is a medical device or an accessory for a medical device should meet the following criteria: the device is specifically intended to benefit patients in the treatment, diagnosis, or prevention of a disease or condition that presents in not more than 12,000 individuals in the European Union per year, and at least one of the following criteria is met:

a) there is insufficiency of available alternative options for the treatment, diagnosis, or prevention of this disease/condition, or

b) the device will offer an option that will provide an expected clinical benefit compared to available alternatives or state of the art for the treatment, diagnosis, or prevention of this disease/condition, taking into account both device and patient population-specific factors.

 

Question:  In which cases could software driving or influencing the use of a (hardware) medical device be qualified as accessory for such device?

Answer: According to Regulation MDR, Article 2(2) “Accessory for a medical device” means:

an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s).

Question: During the audit our Notified Body (NB) reviewer asked to see CE certification (according to MDR Article 23) for the critical part included in our device. We don’t agree with such an opinion. Is our NB correct?

Answer:  According to MDR Article 23 (Parts and components) only “An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device” and needs to comply with MDR.
This means that company which repairs the device by replacing a part or component of a device that significantly changes the performance or safety characteristics or the intended purpose of the device – such item/part/component will be considered medical device and be CE certified; and such entity would be regarded as – a legal entity.

Question: Does a company need to designate a person or persons responsible for cybersecurity within the company?

Response: According to IEC 81001-5-1: 2021-12 Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle (see clause 4.1.2) – the Company needs to designate a person (personnel) responsible for the cybersecurity, same as for other organizational roles. Likewise, a Company should define and document all cybersecurity activities and processes in the Company.

See also our EU MDR & IVDR Certification

Contact us – our experts will provide Gap Analysis MDD-MDR transition.