Hi Andrew,

I have always used Guidance documents to get better clarification on what the regulation is actually looking for. More specifically, I have used multiple MEDDEV guidance documents to make sure that I am following the right path when I am somewhat lost about what should be done. Guidance documents contain non binding roles. As Dr. Simon have mentioned, Guidance document show you a way to achieve compliance but they do not show you the way to compliance. I agree that NB-MED guidance documents may seem to carry the most weight, but remember notified bodies tend usually to follow local jurisdictions of where their headquarters are located. This might mean that they might add more regulations that what is required by the competent authorities. Therefore, I usually look into the MEDDEV first then follow the NB-MED.

Looking forward to see what others think,
Fady

As far as my understanding, Guidance documents are not mandatory but it a template for reading directives. Guidance documents in EU, I would rank NB-MED higher than any other because it is written by the notified bodies which is the key component of the EU and it has the authority to inspect the devices and their findings carry a weight on passing or failing of a device. So to me, this carries the most weight. And component authorities accept their judgement and these component authorities write the MEDDEV Documents. Thus, I would look at NB-MED before anything else. As I do not have actual experience working with such conditions, my answer is based on what Dr. Simon mentioned in the notes and my understanding of the system in EU.

I would say that NB-MED guidance documents are the most useful to follow. The notified bodies have the power to inspect devices and can lead to a suspension or halted sale of the product. This can cost a company a great deal of money, not only modifying the product to make it up to standard, but also in loss of time, product, and manufacturing. To further support, competent authority guidance documents are written by competent authorities, applicable to individual countries. Oftentimes, competent authorities will follow the decision of the notified bodies and this can further apply to a MEDDEV guidance document.

Guideline documents are documents that generally clarifies a directives or regulation, as Dr. Simon mentioned, they are not mandatory but they are considered and accepted as the best way to follow a directive. I would have to agree with most of the forum, that NB-MED guidance documents are the most important and useful to follow since they are written by Notified Bodies and they are the central piece of the EU regulatory structure and the ones that pass or fail the device for CE marking. These guideline documents are telling you what the Notified body will be looking for when inspecting a medical device. To me, NB-MED guidelines are the one to follow in order to unsure the CE mark and start selling the medical device in the EU, since failing of the device results in time and money losses as well as more time and money to be spent in order to fix everything for approval and obtain the CE mark.

I agree with previous posts in regards to NB-MED Guidance Documents being one of the most useful documents. Since it is written by the notified bodies, it is very useful that they do have the authority to assess and verify the clinical evaluations provided by the manufacturers and decide whether to pass or fail any device. Also, they are contracted by the EU and are the central piece of its regulatory structure that performs the necessary risk analysis and identifies undesirable side effects. In addition, the Competent Authorities accept their judgement on the necessary medical devices.
http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_7_1rev_3_en.pdf

The answer that I am about to state is based on the links Dr. Simon posted on this week’s lecture and my understanding of the documents. The Guideline Documents are not mandatory, but they certainly provide a way to follow a directive. I would consider the NB-MED Guidance Documents to be the most useful for getting a device through the regulation process in the EU. In the EU, the Notified Bodies are capable of evaluating devices and the overall process of marketing the device. Additionally, the evaluation by a Notified Body of the products needs to include an opinion of a competent authority and they accept the Bodies’ judgment on the device. The documents state what the Notified Body will be looking for when evaluating a device, and thus, they are essential to the regulation structure because they decide whether the device passes or fails after evaluating the data gathered from the clinical studies that are conducted by the medical device manufacturers.

yes i do believe that Guidance documents are very important because this documents are prepared for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy on a regulatory issue. Guidance documents include, but are not limited to, documents that relate to:
-the design, production, labeling, promotion, manufacturing, and testing of regulated products
-the processing, content, and evaluation or approval of submissions
-inspection and enforcement policies
Guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statue, regulations, or both.

Essentially MEDDEV, NB-MED, and Competent Authority Guidance Documents all have their uses and advantages. However, considering the process of NB-MED bring written by notified bodies and MEDDEV written by competent authorities and lastly competent authority guidance documents written by individual CA's, NB-MED would be the most useful. NB-MED has its uses in providing clarification and lead companies into the correct path to follow directives or regulation in the EU, guidance documents is not mandatory but it is essential to have and follow and save companies time and money to avoid mistakes. In regards on how NB-DEV is useful, its because they are written by the the notified bodies, these have the power to inspect manufacturers, pass or fail a device based on audits and pass or fail when it comes to obtaining a CE Mark which is required to gain approval, which the CA's use as best judgement of the notified bodies.

Guidance documents are the strongest documented consensus of how the directives are interpreted.Among the three guidance documents,NB-MED are the most useful documents.The duties of NB-MED are to receive technical dossier submitted by manufacturer,to assess the manufacturer quality management system,to evaluate evidences from lab ,clinical or animal studies.NB-MED also function as national standard institute and their division with responsibility may participate in writing ISO standards.NB-MED also as a part of contract of National competent authority should participate in vigilance in case they receive reports of adverse incident.If a device needs to be removed from market ,it is the responsibility of NB-MED to suspend its certificate.

I would consider the NB-MED guidance document to be the most useful and most powerful. This is based on the governing power that writes said document. The NB-MED guidance documents are written by the Notified Bodies, which have more central power than the Competent Authorities as they are the central piece of the EU regulatory. They are also the ones that wield the power to approve or fail a device, so it would be in the best interest of manufacturers of devices to follow this for guidance. They are also the body that audits these manufacturers.

All three documents are important in their own way in ensuring the safety of medical devices. As a result of the MEDDEV Guidance Documents and Competent Authority Guidance Documents being written by the Competent Authorities, they do not have the authority to approve medical devices. They also cannot audit or inspect, but are able to take a product off the market if they have a reasonable argument as to why. The NB-MED Guidance Documents are written by the Notified Bodies, so they have more power in approving medical devices. This seems to be the most useful in making sure a device goes through the regulation process in the EU. These documents are written by a group who has the option to inspect manufacturers as they seem fit. In addition, they have the ability to audit which can result in a medical device passing or failing in the market. Once a device is marked as a failure, it prevents the device from further being sold in EU. Of all three documents, the NB-MED Guidance Documents has the most significance in regulating a device.

Based on the EU government, guidance documentation is not necessarily obligated to be followed by law. They are to provide clarity on directives based on standards. The council approves the directives but does not state how to enforce the law. The guidance documents are broken down into three components:
1. MEDDEV: written by the Competent Authority
2. NB-MED: written by notified bodies
3. Competent Authority Guidance Documents: specific to the competent authority of that country that writes it
Personally, the NB-MED guidance document seems to have more credibility out of all other guidance documents because they are written by the notified body. The notified body are the private companies that are contracted by the competent authority to audit and inspect the manufacturer. They would know the most details in terms of providing clarity on a derivative compared to the comparative authority. The MEDDEV guidance document does apply to the entire EU but the people writing it are not in direct contact with the manufacturers. The Competent Authorities get their information about the manufacturer through notified bodies.

I believe the Guidance MEDDEVs is an important guideline. First and foremost they are drafted by the proper authorities that are in charge of being a safeguard for the public health, and guidelines that have that in mind will undoubtedly be useful to follow. As per my additional research, they can go through a consultation process with multiple parties are regularly updated. It is unusual to see a highly followed guideline not having a legal binding. But looking at the research, following these guidelines is very much expected by all interested parties. The guidelines range for many topics and provide multiply templets helpful for the devices.