Have you ever wondered how 28 countries, each with their own competent authority (Ministry of Health), and the many designated notified bodies in the European Union, express (and arbitrate) their collective interpretation of different directives and operational issues associated with the regulation of medical devices? Let's discuss the many facets of the regulations governing medical devices in Europe.
One set of documents pivotal for manufacturers to consider is guidance documents. Don't dismiss their name by virtue of the word "guidance." While "guidance" belies importance, these documents are the strongest documented consensus of how directives or specific parts of a directive are interpreted. And many of the entities involved in the medical device industry in Europe have designated groups that issue these guidance documents. A simple way to think about guidance is as a set of instructions or directions, just as instructions for use are required for certain devices, guidance documents further explain the legislation.
Following is an explanation of the importance of guidance documents and an attempt to unravel the mystery of who issues device guidance and how these documents are issued.
Major Players in the Regulation of Medical Devices in Europe
Numerous entities play a role in assessing, evaluating and modifying regulations for medical devices in Europe; hence, many entities issue guidance documents. As you might imagine, there are many organizations and committees dealing with various issues that are important to specific device categories. However, certain groups exert significant influence.
Let's start with a succinct legislative primer: The European Commission is involved in proposing legislation. In each member state, the competent authorities all have national rules and regulations in addition to the transposed Medical Device Directive (MDD). In addition, notified bodies, such as BSI and TUV, play an active role in the medical device industry.
Similar to the hierarchy that existed for standards, there exists some semblance of a hierarchy for guidance; such documents from the EU Commission are the most significant, and MEDDEV guidance documents are more significant than NB-MED guidelines. And, similar to vertical and horizontal standards, there are "vertical" and "horizontal" guidance documents.
The Major Guidance Documents
EU Commission Guidance - The European Commission was granted the "right of initiative" in the legislative process to propose legislation that is ratified by the European Parliament and Council. In this capacity, the EU Commission also publishes guidance to provide explanations to the directives. As an example, the EU Commission published EU Guidelines on the application of the Directive 89/336/EEC on the approximation of the laws of the member states relating to electromagnetic compatibility. The guidance was developed to explain the "requirements for compliance with the provisions of the EMC Directive." Even more significant, the EU Commission has provided guidance on the "New Approach Standardisation in the Internal Market"- this is an extensive repository of resources.
MEDDEV Guidance Documents - The EU Commission established the Medical Device Expert Group (MDEG). It is composed of delegates from member state competent authorities and other EU well-known organizations including EUCOMED, EDMA, CEN, CENELEC, NB-MED and EAAR. The MDEG is most well known for the guidance documents it publishes, MEDDEV Guidance Documents. These items reflect the consensus position of its members on such issues as the demarcation between the MDD and AIMDD Directive, definition of an accessory, classification of devices, translation procedures and much more. The opinion of this group is not legally binding but is considered the "highest" of guidelines in the industry.
The MDEG meets regularly to discuss common issues and discusses the drafting of new guidance documents. More than 10 sub-groups of the MDEG contribute; some of them include the Market Surveillance Operation Group; Vigilance Expert Group; and New & Emerging Medical Device Technologies Working Group. Currently, 28 MEDDEVs have been issued, and they are all available on the EU Commission Europa Web site. Let's discuss them in more detail.
NB-MED Guidance Documents - The EU Commission and individual countries formed the Notified Body Operations Group (NBOG) in 2000 to address concerns about the inconsistent performance of notified bodies in medical devices and the competent authorities responsible for them. Essentially, the NBOG identifies and communicates "best practices" for notified bodies and reports on their progress at the semi-annual meeting of the Competent Authorities and the MDEG. One member of the NBOG usually produces a written guidance, which is then circulated to the other members for comment.
Notified Bodies issue guidance documents with the moniker NB-MED. These items also can be elevated to MEDDEV status if they are approved by the MDEG. An example of a NB-MED guidance document is NB-MED/2.5.2/Rec 2, titled Reporting of Design Changes and Changes of the Quality System. Twenty-seven NB-MED guidance documents are available on the European Association of Notified Bodies for Medical Devices (TEAM-NB) website.
Competent Authority Issued Guidance Documents
Competent authorities and the National Ministries of Health, in each member state, enforce the medical device directives. Each country has transposed these directives into their national law; therefore, competent authorities also can describe their opinions in guidance documents. Such guidance may be applicable if a manufacturer is distributing its device in a specific member state. As an example, in Ireland, the Medical Devices Department of the Irish Medicines Board issues pertinent guidance. In December, the group issued a guidance document titled, Guide for Manufacturers of System and Procedure Packs Regarding Legislative Requirements.
It is important to know that when this transposition occurs, differences can occur from country to country. Individual competent authorities may have differing interpretations on the meaning of what was originally approved, and additional differences can occur due to simple translation errors.
Why Guidance Matters
Here's an actual illustration of the importance of guidance. On Aug. 11, 2005, the European Commission published Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements to Class III from IIb. This was driven at the request of the competent authorities in France and the United Kingdom. Annex 9 of the original Medical Device Directive 93/42/EEC was amended to reflect the new classification for these devices. After the directive was published, MDEG stakeholders realized that some points in the directive needed clarification and subsequently published a guidance document on Jan. 11, 2007, to help clarify these issues.
The guidance document is a unified interpretation of the meaning and intent of the directive and is not legally binding. Look at it this way: Amendments to directives reflect major shifts in thinking, whereas guidance documents are merely clarifications of existing rules. Reclassification of an entire line of products is a major shift, and therefore, an amendment to the directive was completed.
You can see all of the guidance documents that come out of these groups by visiting the medical devices section of the European Commission's website. All of them also are available in the Library section of our site.
As you can see, the legislation process is complex in Europe, and many different stakeholders are involved. Reviewing the guidance, however, can give you a better understanding of the changes. Guidance documents should be considered as important as law, even though they are not legally binding.