EU medical device (MEDDEVs) guidance doc’s newly rls’ed or updated
The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: Below this article from Christine Ruther are several blog postings thx to Erik Vollegbret of Axon Lawyers but to read them you have to go to the bottom of this posting.
Several European medical device guidance documents (MEDDEVs) have been newly released or updated as noted below. A brief note of significant points is provided.
- MEDDEV 2.12/1 Medical devices vigilance system (UPDATED – March 2012):
o Changes that will likely affect your current procedures are:
§ 2 new report forms (Annex 7 – Trend Report Form and Annex 6 – Periodic Summary Report Form), and
§ updates to 2 existing report forms (Annex 3 – Incident Report Form and Annex 4 – FSCA Form).
o The revised guidance is applicable as of 15JUN12.
o Overall, the content of the guidance has not changed significantly. Minor changes appear in Section 4.5 – EUDAMED, Section 4.18 – Trend Reporting, Section 5.1.2 – Summary Reporting, Section 188.8.131.52 – Negligible Likelihood, Section 5.1.4 – Trend Reports, Section 6.3.1 – Circumstances (Coordinating NCA), Section 6.3.5 – Information between NCAs, Annex 1 – Examples, Annex 2 – Extracts from Directives, and Annex – GHTF Documents Used. The numbering of some Annexes has changed.
o Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1-rev_6_mir_en.pdf. Also see the Manufacturer Incident Report (MIR), http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1-rev_6_mir_en.pdf; How to Use the MIR, http://ec.europa.eu/health/medical-devices/files/meddev/mir_use_en.pdf; and Field Safety Corrective Action report form, Field Safety Corrective Action.
- MEDDEV 2.12/2 Post Market Clinical Follow-up (PMCF) studies (NEW):
o Guidance provides insights into when a PMCF study should be considered, general principles for conducting a PMCF study, use of PMCF study data, and the role of the Notified Body.
o The Notified Body is now required to “verify that PMCF is conducted when clinical evaluation was based exclusively on clinical data from equivalent devices”. Any plan to justify no PMCF study in this case should be reviewed with your Notified Body at the earliest date possible.
o Note that incidents that occur during PMCF studies conducted with CE marked devices within their intended uses are subject to Vigilance reporting requirements.
o The guidance does not apply to IVD devices.
o Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_12_2_ol_en.pdf.
- MEDDEV 2.5/10 Guideline for Authorised Representatives (NEW – January 2012) [only applies with the manufacturer is outside the EU]:
o Guidance clarifies what the Representative is required to do (e.g., keep Declarations of Conformity and Technical Documentation at the disposal of the national authorities) and discusses what the Representative may be requested to do.
o It also clarifies that a Representative is required for devices intended for clinical investigations.
o Per the guidance, a contract is considered vital. I recommend that you review the current contract with your Representative to ensure that all points noted in this guidance are addressed in the contract.
o Available at http://ec.europa.eu/health/medical-devices/files/meddev/2_5_10_ol_en.pdf.
- MEDDEV 2.1/6 Qualification and Classification of stand alone software (NEW – January 2012):
o Guidance walks you through how to determine if software is a standalone device.
o It also describes how to determine its MDD classification or select the IVDD Annex.
o Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf.
- MEDDEV 2.14/1 IVD Medical Device Borderline and Classification issues. A guide for manufacturers and notified bodies (UPDATED – January 2012):
o Guidance walks you through:
§ deciding whether a device is a general laboratory or IVD device;
§ deciding whether a device falls under the IVDD or MDD; as well as
§ addressing kits that contain IVD devices, medical devices and other components.
The manufacturer’s stated intended use is key to addressing these issues.
- MEDDEV 2.2/4 Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products (NEW – January 2012):
o Guidance discusses how to determine, based on mode of action, when IVF/ART products fall under the MDD.
o It describes issues to consider to address each MDD essential requirements along with most market considerations for traceability, vigilance, post-market clinical follow-up, and design modifications.
o It also walks you through how to determine classification (usually Class III per Rule 13 as most incorporate one or more medicinal products).
o Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4_ol_en.pdf.
- MEDDEV 1.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP (NEW – January 2012):
o Guidance is specific to variant Creutzfeldt-Jakob Disease (vCJD) [CJD is commonly called “mad cow” disease].
o As the current Common Technical Specifications (CTS) cannot be adapted easily to vCJD assays, the guidance identifies basic quality requirements for vCJD assays.
o Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_14_4_ol_en.pdf.
The full list of MEDDEVs is available at http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm.
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The next 2 blog postings are thx to Erik Vollebregt who is a Life Sciences and IP (Intellectual Property) lawyer based in Amsterdam and is one of the founding partners of Axon Lawyers. His posting is titled:
+ New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance announced
+ New MEDDEV on authorised representatives: everything you know is wrong
Erik has a blog that I visit frequently for EU MDD & AIMDD information. Erik & I communicate on occasion to discuss various EU issues related around the EU MDD & AIMDD. He has been a great resource of information to Eisner Safety Consultants.