Software in Medical Devices, by MD101 Consulting

QMS and Technical File completeness prior to submission

The annex VII of both regulations contain the following article (bold style added):

Annex VII clause 4.3. Application review and contract
The notified body shall require a formal application signed by a manufacturer or an authorised representative containing all of the information and the manufacturer's declarations required by the relevant conformity assessment as referred to in Annexes IX to XI.
The notified body shall have documented procedures to review applications, addressing:
(a) the completeness of those applications with respect to the requirements of the relevant conformity assessment procedure, as referred to in the corresponding Annex, under which approval has been sought.

Translation in everyday language:

1. You put in place your QMS and make it run a while (say, 6 months),
2. You compile your technical file, with 100% of its content,
3. Then you submit your application,
4. The Notified Body accepts it or rejects it, if they think it is not completed.

So, you can't submit anything to the Notified Body if your QMS hasn't been rubbed to reality for a while, and your technical file is not complete.
Examples:

• You've finished implementing your QMS and have no record on production yet, your Notified Body is prone to refuse to certify the production process,
• You have a clinical evaluation report pending, you know that everything's fine and want to accelerate the process? You can't. You have to wait for the CER to be completed to submit it to the Notified Body.

Advantage: for the Notified Body, they don't loose time and temper with uncompleted or postponed submissions.
Drawback: for the manufacturers, it will take more time to CE mark a device, compared to the directives. Especially, it's not possible to overlap the technical file creation/update with the submission to the Notified Body.

All in all, this looks like 510k submissions, where you shall have everything completed (Refuse to Accept Policy).
But: unlike 510k's, the QMS is included in the submission. Thus, the review by the Notified Body comprises a technical file review, and an audit on site.

QMS Audits, TF Reviews and Non-Conformities

If we continue with the articles at the annex VII, we find:

4.5.2. Quality management system auditing
(b) Based on the audit programme it has drawn up, the notified body shall, in accordance with its documented procedures:
- audit the manufacturer's quality management system, in order to verify that the quality management system ensures that the devices covered conform to the relevant provisions of this Regulation which apply to devices at every stage, from design through final quality control to ongoing surveillance, and shall determine whether the requirements of this Regulation are met,
-(text removed)
- conduct assessments of the technical documentation based on its sampling plan and taking account of Sections 4.5.4. and 4.5.5. for pre-clinical and clinical evaluations, and
-the notified body shall ensure that audit findings are appropriately and consistently classified in accordance with the requirements of this Regulation and with relevant standards, or with best practice documents developed or adopted by the MDCG.

Translation in everyday language:

1. The Notified Body audit your QMS on premises. You're already ISO 13485 certified? No problem, it will speed-up the audit but the audit with MDR criteria is still required,
2. They leave the audit and give you a bunch of non-conformities to resolve,
3. Then they evaluate remotely the technical file,
4. They send you another bunch of non-conformities to resolve,
5. You have 90 days to fix the non-conformities (the delay is set by contract by your Notified Body),
6. If the time elapses, you have to start a new submission from scratch.

Let's do the math on the back of an enveloppe:
You're a very well structured company with products and processes compliant to the MDD and ISO 13485:

• QMS audit: 1 month,
• Answers to QMS major non-conformities (you will have some): 3 months (let's be optimistic),
• Technical File Review: 1 month,
• Answers to TF major non-conformities: 3 months (let's stay optimistic).

Total: about 8 months, but with some overlap between QMS and TF, this will take 6 months after submission of your MDR TF and QMS.

Let's take another enveloppe:
You're a start-up with new products and new processes. You're already ISO 13485 certified on the processes which are already in place (namely design and development and perhaps other processes):

• QMS audit: 1 month,
• Answers to QMS major non-conformities: 3 months to 6 months (after 90 days, BAM! time elapsed),
• Technical File Review: 1 month,
• Answers to TF major non-conformities: 3 months to 6 months (BAM! time elapsed).

Total: about 12 months, or even more if you need more clinical data, with two submissions of your MDR TF and QMS. Two submissions, hence Notified Bodies only accept 2 iterations of corrective actions on non-conformities, within a 90 days timeframe.

This is the new game. CE marking medical devices will take more time with the MDR/IVDR. We have to cope with that.

Fortunately, it's possible to speed up the process by requesting an ISO 13485 certification of your QMS. By doing this, we have a kind of preparation to the MDR audit, since the QMS is reviewed before the CE marking submission. All major non-conformities with regard to regulatory requirements should have been fixed before the CE marking audit.

Be prepared to the submission

The keyword of this post is: completeness.
Thus, we have no other option than being prepared to the review by the Notified Body. Trying to save time before the review by submitting a technical file with poor or uncompleted documentation will turn into a waste of time with Notified Body's major non-conformities.
Spending enough time to prepare a completed technical file documentation at the level of MDR expectations, will save time with the Notified Body.

This was true with the MDD/IVDD/AIMDD. This is all the more true with the MDR/IVDR and the requirement of completeness of manufacturers' submissions.