Medical Devices Newsletter

Newsletter about MDR and IVDR:

We inform you about MDR and IVDR related news.

See the latest updates in the list below or subscribe to our newsletter to get all news via email.

2021

July 22, 2021:


MDCG 2021-20: Instructions for generating CIV-ID for MDR Clinical Investigations – Link

July 22, 2021:


New Notified Body designated under MDR: Eurofins Product Testing Italy S.r.l (NB 0477) has received its designation under MDR – Link

July 20, 2021:


Harmonised Standards (MDR): Implementing decision of harmonised standards for medical devices in support of MDR EU 2017/745 – Link

July 20, 2021:


Harmonised Standards (IVDR): Implementing decision of harmonised standards for medical devices in support of IVDR EU 2017/746 – Link

July 15, 2021:


New Forms for Notified Bodies in the scope of the MDR and the IVDR:

MDCG 2021-15: Application form to be submitted by a conformity assessment body when applying for designation as a Notified Body under the MDR – Link

MDCG 2021-16: Application form to be submitted by a conformity assessment body when applying for designation as a Notified Body under the IVDR – Link

MDCG 2021-17: Applied-for scope of designation and notification of a conformity assessment body – MDR – Link

MDCG 2021-18: Applied-for scope of designation and notification of a conformity assessment body – IVDR – Link

July 15, 2021:


MDCG 2021-19: Guidance note integration of the UDI within an organisation’s quality management system – Link

July 13, 2021:


MDCG 2021-14: Explanatory note on IVDR codes – Link

July 12, 2021:


MDCG 2021-13 rev.1: Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR – Link

July 2, 2021:


Clinical Evaluation Consultation Procedure (CECP): Opinion in the context of CECP – Link

June 23, 2021:


MDCG 2021-13: Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR – Link

June 16, 2021:


DEKRA Certification B.V (NB 0344) designated under IVDR: Check their scope – Link

June 15, 2021:


Q&A: European Medical Device Nomenclature (EMDN) – Link

June 8, 2021:


MDCG 2021-11: Guidance on Implant Cards – “Device Types” – Link

June 7, 2021:


Joint implementation and preparedness plan for IVDR EU 2017/746 medical devices:Link

June 4, 2021:


MDCG 2021-12: FAQ on the European Medical Device Nomenclature (EMDN) – Link

June 4, 2021:


MDCG 2021-10: The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices – Link

May 27, 2021:


MDCG 2021-09: MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers  – Link

May 26, 2021:


Application of Regulation on Medical Devices: EU rules to ensure safety of medical devices – Link

May 26, 2021:


Stronger rules on medical devices – Link

May 26, 2021:


EU notification (EU-Switzerland): Status of the EU-Switzerland mutual recognition agreement (MRA) for medical devices  – Link

May 26, 2021:


Switzerland is official a third-party country: Today the MepV 812.213 – May 26, 2021 has been published  – Link

May 26, 2021:


MDR is now law: Today MDR EU 2017/745 comes into force and officially replace the MDD 93/42/EEC and AIMD 90/385/EEC  – Link

May 21, 2021:


MDCG 2021-08: Clinical investigation application/notification documents  – Link

May 19, 2021:


MRA between EU and Switzerland: The Federal Council of Switzerland decided to update MedDO / MepV to act as a third-party country – Link

May 18, 2021:


UDI helpdesk is live: It helps the economic operators in the implementation of the requirements introduced by the new UDI system – Link

May 17, 2021:


MDCG 2021-7: Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices – Link

May 12, 2021:


Update MRA between Switzerland and EU: Information for Swiss Medtech regarding transition period and more – Link

May 4, 2021:


Update of MDCG 2021-1 (Rev.1): Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional – Link

April 30, 2021:


Factsheet: Factsheet for Manufacturers of Implantable Medical Devices – Link

April 28, 2021:


Factsheet: Factsheet for Class I Medical Devices – Link

April 27, 2021:


Revision 4 of MDCG 2018-1: Guidance on BASIC UDI-DI and changes to UDI-DI – Link

April 22, 2021:


MDCG 2021-6: MDR 2017/745 – Q&A regarding clinical investigation – Link

April 16, 2021:


MDCG 2021-5: Guidance on standardisation for medical devices – Link

April 9, 2021:


MDCG 2021-4: Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 – Link

April 9, 2021:


MDR and IVDR implementation rolling plan: This rolling plan contains a list of identified essential implementing acts and other relevant initiatives that the Commission has adopted or intends to adopt in the future – Link

April 7, 2021:


New Notified Body designated under MDR: Eurofins Expert Services Qy (Nb: 0537) – Link

April 1, 2021:


MRA Switzerland-EU: Important contents of the Contingency MedDO – Link

March 23, 2021:


Infographic: Is your Software a Medical Device – Link

March 15, 2021:


MDCG 2021-3: Q&A on Custom-Made Devices – Link

March 15, 2021:


MDCG 2021-2: Guidance on state of the art COIVD-19 rapid antibody tests – Link

March 8, 2021:


Notified Bodies under MDR/IVDR: Overview of Notified Bodies at each stage of MDR/IVDR qualification process – Link

March 5, 2021:


EUDAMED: Delay of EUDAMED module 2 and 3 – Link

February 26, 2021:


MDCG 2021-1: Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional – Link

February 8, 2021:


Management of Legacy Devices – Link

January 18, 2021:


Factsheets: Factsheets on the main areas of the medical device sector activities – Link

January 11, 2021:


EU Commission notice – Audits: Commission Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed in the context of quality management system assessment – Link to document EN / Link to document DE

January 9, 2021:


SGS FIMKO OY (NB 0598 (ex-0403)) has received its designation under MDR. Check their scope with the following – Link to scope

2020

December 5, 2020:


UDEM Adriatic d.o.o. (NB 2696) has received its designation under MDR. Check their scope with the following – Link to scope

December 2, 2020:


MDCG 2020-17: Questions and answers related to MDCG 2020-4 – Link to document

December 1, 2020:


EUDAMED economic operator registration is live: Important for all who act as economic operators in the EU (manufacturers, authorized representative, importer, system/procedure pack producer ) – Link to EUDAMED platform

November 27, 2020:


TüV Rheinland LGA Products GmbH (NB 0197) has received its designation under IVDR. Check their scope with the following – Link to scope

November 26, 2020:


MDCG Events for 2021: New MDCG events plan – Link

November 24, 2020:


MDCG Events 2020: Updated MDCG events plan – Link

November 13, 2020:


MDCG 2020-16: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 – Link

November 2, 2020:


Draft standardization request: MDR and IVDR – Link

October 29, 2020:


List of MDCG members: Overview – Link

October 27, 2020:


MDCG development overview October 2020: Ongoing guidance development within MDCG Subgroups – October 2020 – Link

October 24, 2020:


Overview of Notified Bodies under MDR and IVDR: The EU Commission has updated the designation overview of MDR and IVDR Notified Bodies – Link

October 22, 2020:


Guide to using EUDAMED: Actor registration module for economic operators – Link

October 14, 2020:


MedTech Europe: Concerns about the implementation progress of IVDR – Link

September 16, 2020:


3EC International a.s (NB2265) has received their designation under MDR – Link

August 20, 2020:


MDCG 2020-15: MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States) – Link

August 19, 2020:


Regulation 2020/1207: Reprocessing of single-use devices under MDR – Link

August 12, 2020:


UDI System: FAQ – Link

August 8, 2020:


DQS Medizintechnik GmbH (NB 0297) has received its designation under MDR. Check their scope with the following – Link

August 7, 2020:


MDCG 2020-14: Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) – Link

July 17, 2020:


MDCG 2020-13: The EU-Commission has updated the “Clinical evaluation assessment report template” – Link

June 29, 2020:


MDCG 2018-3 Rev.1: The EU-Commission has updated the “Guidance on UDI for systems and procedure packs” – Link

June 17, 2020:


  • TÜV SÜD (NB 0123) has received its designation under IVDR. Check their scope with the following – Link

June 10, 2020:


  • MDCG 2020-12: Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissue – Link

May 28, 2020:


  • MDCG 2020-11: Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013 – Link

May 19, 2020:


  • EU-Commission: Guidelines on the adoption of union-wide derogations for medical devices in accordance with article 59 of regulation MDR (EU) 2017/745 – Link

May 15, 2020:


  • New Notified Body designated under MDR: Intertek Medical Notified Body AB – Link

May 14, 2020:


  • MDR EU 2017/745 consolidated text: MDR consolidated text (including corrigendum 1 and 2 + postponement until May 2021) – Link

May 13, 2020:


  • MDCG 2020-10/2: Clinical Investigation Summary Safety Report Form v1.0 – Link
  • MDCG 2020-10/1: Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 – Link
  • MDCG ongoing guidance development: Update May 2020 – Link

April 27, 2020:


  • MDCG 2020-9: Regulatory Requirements for Ventilators and Related Accessories – Link

April 25, 2020:


  • The Notified Body MDC is designated under MDR: Check their scope Link

April 24, 2020:


  • BREAKING NEWS: MDR officially postponed until May 26, 2021. Check  the published amendment – EN / DE / FR / IT / ES
  • MDCG 2020-8: Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies – Link
  • MDCG 2020-7: Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies – Link
  • MDCG 2020-6: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies – Link
  • MDCG 2020-5: Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies – Link

March 17, 2020:


  • MDCG 2020-3: Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD  – Link
  • MDCG 2020-2: Class l Transitional provisions under article 120 (3 and 4) – Link
  • MDCG 2020-1: Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software  – Link

March 16, 2020:


  • MDCG 2019-8 v2: Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices – Link
  • MDCG 2018-1 v3: Guidance on BASIC UDI-DI and changes to UDI-DI – Link

January 10, 2020:


  • Basis of EUDAMED nomoclature will be CND (Classificazione Nazionale Dispositivi medici) – Link
  • The CND Nomenclature – background and general principles – Link

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