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MDD Regulations: What I Wish I Had Known

Since the legal manufacturer is ultimately responsible for the device being placed on the market, it is critical that sufficient detail about the subcontractor’s work is known in order to address the ERs.

Regardless of whether the contributing party has obtained regulatory clearance, it is still the responsibility of the legal manufacturer to ensure compliance with the MDD. In addition, if a significant subcontractor does not hold an ISO 13485 Certificate from an EU/EEA NB, then an audit of that subcontractor may be required prior to Annex II – Annex VI certification. An ISO 9001 Certificate may not be sufficient.

NB practices may vary, so the legal manufacturer should discuss this with their NB prior to seeking certification. The manufacturer can verify if the body that issued the ISO 13485 certificate is an NB (or their affiliate) by reviewing the Nando (New Approach Notified and Designated Organizations) Information System data in the European Commission website  .

Article 5 of the MDD states that compliance with applicable ERs can be presumed if conformity with Harmonized Standards can be demonstrated. Knowing what is harmonized, however, is not always straightforward. One key resource is found in the Medical Device information online. This site identifies harmonized standards, whether they supersede another standard, and the date after which the presumption of conformity ceases. However, this site is not updated in real time and there may be standards (or versions) that are harmonized and yet are not listed.

Once the standard is published, however, review of the standard itself should clarify whether it is harmonized. Harmonized standards are considered horizontal if they apply broadly across devices or vertical if they apply only to a subgroup of devices, but all contain an Annex (Z) that describes the scope of ERs for which compliance can be presumed if conformity is met. While conformity with harmonized standards is not required to demonstrate compliance with the ERs, ER compliance justifications must be provided for solutions when relevant harmonized standard sections are not applied in full.

One of the biggest differences between MDD and U.S. FDA regulations is the requirement that, regardless of device classification, conformity with the ERs must include a risk appropriate Clinical Evaluation Report (CER) on the subject device or equivalent devices that is conducted by an individual with appropriate qualifications to evaluate the technology, research methodology and clinical diagnosis/management. For implantable and EU Class III devices, a clinical investigation is also required unless duly justified to rely on existing clinical data.

Many manufacturers mistakenly interpret this requirement to mean that only a literature review and predicate device substantial equivalence (similar to what is required in a US 510[k]) must be demonstrated. Four documents (EN ISO 14155-1, GHTF N2R8, MEDDEV 2.7.1 and MEDDEV 2.12-2) all discuss what is required to fulfill this requirement and detail multiple parameters that are to be included in the CER.

Before any clinical data is even considered as being applicable, equivalence between the subject and comparable devices must be demonstrated based on similarity of clinical, technical and biological parameters with special attention to the performance, principles of operation, and materials. If differences are identified, an assessment must be documented to demonstrate the significance these differences might have on safety and performance.

Assuming equivalence can be demonstrated, the clinical data must also show that the device safety and performance is consistent with state of the art. It is not sufficient to be equivalent to a marginally performing device if state of the art performance is significantly better. For devices containing or utilizing animal tissue (per Directive 2003/32/EC), additional clinical benefit must be demonstrated beyond synthetic or lower risk animal devices as well as demonstrating acceptable risk. Short- or medium-term (relative to intended device lifetime) clinical data may be sufficient to justify not performing a clinical investigation, but may not be sufficient to warrant not performing Postmarket Clinical Follow-up (PMCF).

Annex X of the MDD requires that the clinical evaluation and its documentation must be actively updated with data obtained from the postmarket surveillance (PMS). Hazards identified during PMS must also be actively compared to those identified in the risk management file, which must be updated if new hazards are identified or previous assumptions are found to be no longer valid. The linkage between risk management and PMS is fundamental to continued device certification and is frequently missed.

Even though the CER is a required element for certification, completion is often seen only as a regulatory hurdle and left to the end of the development cycle.

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