What are the 6 New Essential Requirements?

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Annex I of the European Medical Device Directive (http://bit.ly/M5MDD) is titled “Essential Requirements.” Most companies demonstrate that their device meets the 13 Essential Requirements (ERs) by creating an Essential Requirements Checklist (ERC). I have no idea what the origin of the ERC is, but you know that regulators love tables and checklists. This particular checklist is so commonly used that the Global Harmonization Task Force (GHTF) included an example of an ERC, called an “Essential Principles Checklist” (EPC) at the end of a guidance document on how to create Summary Technical Documentation (STED) for In Vitro Diagnostic devices (http://bit.ly/STEDIVD)—which is now maintained on the IMDRF.org website.

On September 26, 2012, the European Commission released a proposal for new EU Medical Device Regulations (http://bit.ly/EUProposal). This proposal still includes ERs in Annex I, but there are 19 ERs in the proposal. One regulatory professional recently sent me a follow-up question in response to an audio seminar I conducted in November (). Her question was, “What are the six new ERs?”

A few of the early reviews of the proposal indicated that there were no significant changes, but I have learned the hard way that you should always go to the source and verify the information for yourself (i.e. – Genchi Genbutsu). Here’s what I found:

General Requirements (ER 1-6a)

1. No real change to this requirement.
2. This requirement was reworded to clarify the intent (see Annex ZA of EN 14971:2012 for more info @ http://bit.ly/ISO14971-2012changes).
3. It appears as though the Commission thought the current ER 3 was redundant and the requirement was addressed by ER 1 and ER 5 already.
4. This is now the new ER 3, and the requirement now clarifies how Notified Bodies shall apply this requirement in cases where a lifetime of the device is not stated.
5. This is now the new ER 4, and there is no real change.
6. This is now the new ER 5, and the wording has been clarified.

ER6a is conspicuously missing from the proposed ERs, but don’t get excited. Clinical Evaluations are still required as part of the Technical Documentation in Annex II, Section 6.1c: “the report on the clinical evaluation in accordance with Article 49(5) and Part A of Annex XIII.”

Chemical, Physical & Biological Properties (ER 7)

ER 7.1 has one new requirement: “d) the choice of materials used, reflecting, where appropriate, matters such as hardness, wear and fatigue strength.” ER 7.2 and 7.3 remain unchanged. ER 7.4 has been simplified to what is proposed as the new, shorter ER 9. ER 7.5 is now the new ER 7.4, and the changes reflect the current status of phthalate regulations and similar issues. ER 7.6 is now the new ER 7.5, but there is no change to the content. The new ER 7.6 requires that manufacturers address the risks associated with the size and properties of particles—especially nanomaterials. The changes associated with this section will impact certain device types more than others—such as orthopedic implants.

Infection & Microbial Contamination (ER 8)

ER 8 is still ER 8, but ER 8.1 is now prescriptive regarding design solutions and the current ER 8.2 is now the new ER 10. The new ER 10 is expanded and references the new EU Regulations regarding devices manufactured utilizing tissues or cells of animal origin: Commission Regulation (EU) No 722/2012 of 8 August 2012 (http://bit.ly/AnimalTissueReg). The new ER 8.2 is a new requirement that was an oversight of the MDD, and the new ER 8.7 now clarifies that the labeling must differentiate sterile and non-sterile versions of the product; packaging is no longer an acceptable mechanism for differentiation. The balance of ER 8 remains unchanged.

Construction & Environmental Properties (ER 9)

This ER is now identified as the new ER 11, and this section is expanded. This reflects the emphasis on the need to evaluate the safety of devices with accessories, compatibility with other devices, and the affects of the use environment.

Devices with a Measuring Function (ER 10)

This ER is now identified as the new ER 12, but ER 10.2 from the current Directive appears to be missing. What’s up?

Take a look at the new ER 11. ER 10.2 is now the new ER 11.6.

Protection Against Radiation (ER 11)

This ER is now identified as the new ER 13, but there is nothing new.

Requirements for Devices Connected to or Equipped with an Energy Source (ER 12)

ER 12.1 and 12.1a are now ER 14. This section is specific to software requirements and has more detail than the current Directive. IEC 62304:2006, “Medical device software – Software life cycle processes,” is the Standard that will be expected by Notified Bodies as a reference for ER 14. ER 12.2 through ER 12.6 are now ER 15, but there is nothing new. This Section ER 12.7 and its sub-parts are now addressed by ER 16. ER 12.8 and its sub-parts are now addressed by ER 17.

Information Supplied by the Manufacturer (ER 13)

This is now identified as ER 19: “Label and Instructions for Use.” This section is simplified from ER 13 (i.e. – there are fewer sections), but this ER does not seem to be any shorter. ER 19.1 has sub-parts a-g, and this ER section incorporates the concepts previously addressed by ER 13.1, 13.2, 13.4 and 13.5. ER 19.2 is a new and improved version of the previous ER 13.3 specific to labeling requirements. This labeling section is expanded from sub-parts “a” through “n” to “a” through “q”. The UDI requirement is sub-part “h”. ER 13.6 is now ER 19.3 specific to the instructions for use (IFU). This section is expanded from sub-parts “a” through “q” to “a” through “t”.

The number of sub-parts to ER 19.3 doesn’t reflect the additional requirements for IFUs that are proposed by the Commission. The sub-sections of this part warrant special attention. Items that frequently are found missing from IFUs on the market today include:

1. ER 19.3c – performance intended by the manufacturer
2. ER 19.3h – installation and calibration instructions
3. ER 19.3k – how to determine if a re-usable device should be repaired/replaced
4. ER 19.3m – restrictions on combinations with other devices
5. ER 19.3o – detailed warning information
6. ER 19.3p – information about safe disposal of the device
7. ER 19.3t – notice to user/patient to report adverse events

ER 18 – Use by Lay Persons

This is a short section, but the requirement is new. There are now additional requirements for products intended for use by a lay person. The Risk Management Report, Design Validation, and Clinical Evaluation Report will need to include specific evidence to demonstrate conformity with this ER. The Post-Market Surveillance Plan for these products should carefully verify the accuracy of risk estimates. Post-Market Clinical Follow-up (PMCF) Studies would be challenging in the past, but the prevalence of social media and product registration databases may facilitate conducting PMCF Studies for these products in the future.

Australia & Canada

There is also an EPC that is required by the Therapeutic Goods Administration (TGA) in Australia (http://bit.ly/EPCTGA) and by the Therapeutics Product Directorate (TPD) in Canada (http://bit.ly/CanadianSTED). If you would like to learn more about the Essential Principles of Safety and Performance you should also review the GHTF guidance document on this topic (http://bit.ly/EPSafetyPerf) on the IMDRF.org website. This 2012 version of the document supersedes GHTF/SG1/N041:2005.

I have observed approval of products where the European ERC was submitted in lieu of an EPC for Australia and Canada. I guess they are a little more rationale than some other regulators, but if you have experienced any “push back” regarding this approach please share this by posting a comment or emailing me: rob@13485cert.com.

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New Draft EU Regulations may be speculation now, but the crowd knows a secret.

Right now the precise content of the new draft EU regulation is defined but unclear. We know what is going to change, but the final language of the draft is still a “work in progress.”

Therefore, I am using the theory that the “crowd mind” collectively may be more accurate than any one source–at least until the release. I started gathering information from several different regulatory experts throughout Europe and the US.

Essentially what we know is:

1. this will be a regulation instead of a directive

2. the regulation will have a similar structure of articles and annexes, but we can expect the document to grow

3. the device classification section will be a risk-based classification similar to the GHTF guidance (IVD’s are expected to be A, B, C, D)

4. the requirements for Notified Bodies will be stricter, but we expect rotation of lead auditors–not actual Notified Bodies

5. the unannounced audits will probably resemble factory inspections as performed by other GHTF countries

6. the vigilance requirements and post-market-surveillance are expected to become more consistent between Competent Authorities and between Notified Bodies–including the addition of PMCF Protocols and Reports becoming part of the Technical Documentation required for Design Dossiers (the CMC should help achieve this)

7. there will be new requirements for economic-operators (i.e. – importers and distributors)

8. the Authorized representative agreements will become mandatory for the Technical Documentation as well (see the new MEDDEV from earlier this year…I wrote a blog about it on my 13485cert.com website, but Erik Vollebregt wrote a much more thorough blog on this topic)

9. tougher regulation of reprocessed / re-manufactured devices

10. minimum requirements for CE Certificates–including the addition of the GMDN codes to the certificate

11. implementation is expected in 2015/2016

As I gather more information, I am thinking about just editing this posting–instead of posting a new blog.

Please email me or comment on what information you have learned or what you want to know.

If you know of a website with information posted, please share it and I will add it to this posting.

The New EU Regulations – 21 Days and Counting!

The EU Directive will become Regulations…but when? September 26 the proposed regulations are scheduled to be released in draft form. Plans for implementation of the Interim Measures have already begun, but the regulations will not be finalized for 18-24 months while the politics takes over. My magic 8-ball tells me that there is a precedent on this side of the pond that can help us predict the future.

A few weeks ago I published a posting with a cheeky Brit–Lily Allen. Here’s one of Lily’s own favorites by a another talented British singer, song writer named Kate Nash.

Throughout the history of healthcare regulations worldwide there have been three rules that are never broken:

1. Regulations always get tougher.
2. Regulations are only partially effective.
3. Regulations cost everyone more money.

The PIP scandal lit a fire under the European Parliament, the Council and Notified Bodies. Now all three stakeholders are fighting to show the public that they are doing everything they can to ensure safety. Unfortunately, no matter what changes are made it is extremely difficult to prevent unethical behaviors.

Before I make predictions, we all need to remember that there is a larger news story–the European Economy.

The status of the European Economy will have the greatest impact on new regulations. My best evidence is the US FDA.

The FDA has been trying to improve the turnaround on submission reviews for my entire career. For a period of about 8 years, matching closely with the Presidential terms of George W. Bush, it seemed to get easier to get products through the FDA logjam. Then the global economy tanked and political winds changed in 2009.

Over the past three years, Republican’s have gained power and Congress is now pushing the FDA to actually improve the metrics for product approval. The FDA will now have 200 additional reviewers, and every plan for improving turnaround that has been tried is back on the table.  The FDA was given the funds to grow its army of inspectors first, and now the FDA is granted additional funds to hire additional reviewers and train them.

The European Union includes countries that are struggling to provide basic services, while other countries don’t want to bail their European neighbors out of debt. How is the European Parliament and the Council going to increase regulation of medical devices when everyone knows that regulations will cost more money?

The short answer is…they can’t.

One of two things must happen before true change can occur:

1. another healthcare scandal could trigger this change, or
2. the economy could improve.

Based upon the sluggish recovery of the US economy, I don’t see how #2 will happen in Europe during the next 18-24 months. I can’t predict #1, but historically scandals are years apart.

MAGIC 8-BALL TIME

I predict that the draft regulations will get watered down during the co-decision period. The most popular legislative tool is the “transition period”. For example, UDI legislation was passed in 2007 in the US but the proposed rule was not published by the FDA until 2012. The proposed rule includes a 7-year transition period for implementation of the new rule.

If the new EU regulation is finalized in 18-24 months, we can expect a long transition period during which various pieces of the regulations will be implemented. This transition period is essential for Notified Bodies to gradually increase their staff and for training new auditors. This will also give companies several years to organize their own plans for addressing the new regulations.

The one change I predict to happen quickly is consolidation. 60+ Notified Bodies are more expensive for the EU to support than a few large Notified Bodies. The FDA is a single, centralized regulatory body. The EU will not achieve the same degree of centralization, but I predict “a great consolidation”.

My final prediction is related to the vigilance process. In the US the MDR process has become highly automated and electronic submissions with a public database are the norm. This has allowed the FDA to rely on data analysis to identify problems and redirected the burden of data entry from the FDA to industry. We can expect Europe to follow this trend, by centralizing all vigilance reporting. The only remaining question about vigilance is how long will the transition period need to be for revision 8 (of MEDDEV 2.12/1).

ISO 14971 – Buy the new 2012 version?…comment please

I’m sure that there are some that disagree with my determination that the latest revision of EN 14971, revision 2012, is unnecessary (the European Commission certainly does).

 You will have to go to my website to read my cheeky posting on this topic.

And here’s another cheeky attitude from the UK…(sorry, this is not a family channel).

Therefore, I would like to clarify why I feel this way by reviewing how risk is addressed in the MDD (93/42/EEC as modified by 2007/47/EC).

1. The term risk is mentioned only 4 times in the Articles in the MDD
2. The term risk is mentioned once in Annex II and III, twice in Annex VII, and three times in Annex VIII and X—for a total of 10 times.
3. The other 41 times risk is mentioned are in the Essential Requirements (i.e. – Annex I).

When companies submit a Design Dossier for review by a Notified Body, an Essential Requirements Checklist is included. This references, in table format, how all the requirements of Annex I are being met—including those related to risks. Throughout Annex I, a similar phrase is repeated many times. For example, in the first Essential Requirement (ER1) it states: “…any risks which may be associated with [a device’s] intended use [shall] constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.” In ER2 it states: “the manufacturer must…eliminate or reduce risks as far as possible…”. There is no room in the MDD for consideration of cost or economic impact when the manufacturer is designing a device with regard to risks and benefits.

If a company’s Risk Management Procedure has been found to be acceptable by a Notified Body, and the company has addressed all the Essential Requirements (ERs) with regard to risk, then there should be no impact from these 7 deviations identified in EN 14971:2012. However, if your company has not addressed each of these ERs, then you might want to consider each of these areas:

1. Treatment of negligible risks
2. Discretionary power of the manufacturer as to the acceptability of risks
3. Risk reduction “as low as possible” (ALAP) verses “as low as reasonably possible” (ALARP)
4. Discretion as to whether as risk benefit analysis needs to take place
5. Discretion as to the risk control option/measures
6. Deviation as to the first risk control method
7. Information of the users influencing the residual risk

My final advice is to review Annex I and Annex X from the perspective of risk management. You may realize that you have some gaps that nobody noticed. After all, audits are just a sample.

PS – I think it’s ironic that the origins of the ALARP principle are UK case law (see link above).