There are two primary websites to check for new and revised European Medical Device Regulations. The first location is the Europa website, where the three “New Approach” directives and proposed European Medical Device Regulations (EMDR) can be found. There is also a webpage on the Europa website for guidance documents. The following website is managed by Team-NB–a group of Notified Bodies.
Europa Website for Locating European Medical Device Regulations
When you check the Europa website for new and revised medical device regulations, the three most important pages to check are:
- http://bit.ly/EUrevisions – On-going revision of the medical device directives.
- http://bit.ly/EU-current-legislation – Current medical device directives
- http://bit.ly/MEDDEV – Guidance MEDDEVs
The first page provides periodic updates on the status of the proposed EMDR. The most recent update on this page was September 26, 2012. If you are following this carefully, and you understand the European legislative process, then you know that there was a vote by the ENVI committee reviewing the EU Commission’s proposal in September 2013. You also would know that the Plenary Vote on the proposal occurred in October 2013. Now, the European Parliament has mandated that the rapporteurs negotiate a final text with the Council–which is going slower than Parliament would like.
The second page has the current legislation. It is not always obvious if amendments have been made. Therefore, you need to review each of the directives to see if it is applicable. The last significant change to the MDD was the M5 version on March 21, 2010 (i.e., amendment 2007/47/EC to 93/42/EEC). There was a commission implementing regulation on September 4, 2013. Two amendments were released in 2012: 1) electronic instructions for use, and 2) medical devices manufactured with tissues of animal origin.
Finally, the third page lists each of the guidance MEDDEV documents. This list also identifies the date of the most recent version for each MEDDEV. The most recent change was to the vigilance reporting guidance document in January 2013.
The website for Team-NB is http://bit.ly/Team-NB. On the home page, there is a navigation bar listing archived documents by year. In 2012, there were nine documents released. Several of these documents are related to the PIP Scandal (http://bit.ly/MHRAReport), which is now old news, but there was one guidance document discussing the transition plans for IEC 60601-1. There were another 12 documents released in 2013. The four most recent documents are confidentiality statements, and five are auditor attestations. Therefore, there are only three new documents of importance to manufacturers:
- http://bit.ly/Team-NB-eIFU – guidance on the implementation of electronic Instructions For Use (eIFU)
- http://bit.ly/CoCNBV3 – 3rd version of the Notified Body Code of Conduct
- http://bit.ly/Team-NB-IEC62304 – FAQs for the implementation of EN 62304
The first document explains two positions from Team-NB. The first position identifies labeling requirements and the use of harmonized symbols for companies implementing eIFUs. The second position indicates that implementation of eIFUs is considered a significant change in the QMS that requires:
- Notified Body notification before implementation, and
- a list of documents needed by Notified Bodies as objective evidence of readiness for implementation.
The code of conduct includes important details about how the Notified Bodies plan to change the auditing process and qualification of certification auditors to address concerns of the European Council. This includes specific interpretations as to the duration of audits, the duration of an initial Design Dossier review, and the initial plan for unannounced audits by Notified Bodies.
The third document contains 73 frequently asked questions and the response to these questions by Team-NB. There are also four annexes. The 73 questions are organized into the following seven sections:
- Scope of EN 62304
- Placing Software as a MEDICAL DEVICE on the Market
- Life-cycle Processes
- Risk Assessment and Risk Management
- Classification and Segregation
- Specifications, Testing, and Tools
- SOUP and Legacy Software
Review each source of information and determine if the document impacts your organization’s quality system and procedures. This gap analysis should be performed by someone familiar with the specific process(es) addressed by the regulations. The most likely actions to be taken are:
- initiate specific changes to existing procedures
- create new procedures, or
- initiate a quality plan for more substantial changes to your quality system
If you need more help preparing for your management review, here’s a link to a free webinar I recorded: http://bit.ly/Clause5-6. You will also receive a management review slide deck.