24. April 2020
Today the Commission published for new MDCG Guidance documents: + MDCG 2020-8 Guidance on PMCF Evaluation Report Template April 2020 + MDCG 2020-7 Guidance on PMCF Plan Template April 2020 + MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices April 2020 + MDCG 2020-5 Guidance on Clinical Evaluation – Equivalence April 2020
16. March 2020
The Commission updated the MDCG 2019-8 concerning the implant card to version 2. (The previous versionMDCG 2019-8 V1 is no more available on the commission website) As the MDCG Guidance document itself does not have a reference to the version or publication date, it is important to verify the version used. The major difference is the introduction of the UDI Symbol and the requirement to identify the UDI-DI.
16. March 2020
Although the strategy for the transition to the MDR should be "NO CHANGE" on any device that shall be sold utilizing the MDD Certificate after 2020-05-26 (so called "legacy devices") the original wording given in the MDR is "NO significant change". With the newly published MDCG 2020-3 the EU Commission published further clarification on how to interpret the phrase "significant change" for products under Art. 120. Like comparable Guidances in the USA, Canada, Singapore etc. the Guidance is using...
06. January 2020
The European Commission published the first EU Guidance on Cybersecurity: MDCG 2019-06. This document addresses the aspects: Basic Cybersecurity Concepts Secure Design and Manufacture Documentation and Instructions for use Post-Market Surveillance and Vigilance The last chapter compares the current state of the existing guidances under the headline: Other Legislation and guidance: EU and International For the practical approach to the question what are the known hazards on cybersecurity the...
18. December 2019
The guidance MDCG 2019-15 includes a comprehensive overview of the manufacturers‘ obligations for all Class I products. It also gives some further clarification concerning the "Authorized Representative": A manufacturer with a registered place of business outside the Union will designate a sole authorised representative, at least per each generic device group, according to a written mandate. At the same time it includes further specifications of the manufacturers' obligations: The...
01. July 2019
The MDCG is giving further guidance concerning the ‘person responsible for regulatory compliance’ (PRRC) The document MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC) explains several specific questions around the PRRC, such as: Can the PRRC be located outside the EU? Can one individual be the PRRC for a manufacturer and its authorised...
07. June 2019
The latest MDCG Guidance includes "Questions and Answers, relating to Notified Bodies" for the application of the MDR. Although the focus as identified in the title are the Notified Bodies some interesting information for the manufacturers can be found as well. Just to name two topics: Auditing of subcontractors OBL situation under the MDR