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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
August 20, 2021:
MDCG 2021-23: Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – Link
August 19, 2021:
Notified Body DMED SAS (NB 0459): DMED SAS received its designation according to EU IVDR 2017/746 – Link to scope document
August 18, 2021:
MDCG 2021-22: Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 – Link
August 10, 2021:
Swissmedic: Obligations of Economic Operators in Switzerland according to the new Medical Device Ordinance (MedDO: SR 812.213) – Link
August 3, 2021:
MDCG 2021-21: Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices – Link
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 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 7, 2021:
Joint implementation and preparedness plan for IVDR EU 2017/746 medical devices: – 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:
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 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 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
March 8, 2021:
Notified Bodies under MDR/IVDR: Overview of Notified Bodies at each stage of MDR/IVDR qualification process – Link
February 26, 2021:
MDCG 2021-1: Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional – 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 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 13, 2020:
MDCG 2020-16: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 – 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
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 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 14, 2020:
- MDR EU 2017/745 consolidated text: MDR consolidated text (including corrigendum 1 and 2 + postponement until May 2021) – Link
May 13, 2020:
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