Quick Link: Guideline | Gap Assessment | Implementation
Quick Link: Guideline | Gap Assessment | Implementation
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.
UK: MHRA has informed to do a twelve-month extension to the current standstill period – Link
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
Notified Body DMED SAS (NB 0459): DMED SAS received its designation according to EU IVDR 2017/746 – Link to scope document
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
Swissmedic: Obligations of Economic Operators in Switzerland according to the new Medical Device Ordinance (MedDO: SR 812.213) – Link
MDCG 2021-21: Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices – Link
MDCG 2021-20: Instructions for generating CIV-ID for MDR Clinical Investigations – Link
New Notified Body designated under MDR: Eurofins Product Testing Italy S.r.l (NB 0477) has received its designation under MDR – Link
Harmonised Standards (MDR): Implementing decision of harmonised standards for medical devices in support of MDR EU 2017/745 – Link
Harmonised Standards (IVDR): Implementing decision of harmonised standards for medical devices in support of IVDR EU 2017/746 – Link
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
MDCG 2021-19: Guidance note integration of the UDI within an organisation’s quality management system – Link
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
Clinical Evaluation Consultation Procedure (CECP): Opinion in the context of CECP – Link
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
Joint implementation and preparedness plan for IVDR EU 2017/746 medical devices: – Link
MDCG 2021-10: The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices – Link
MDCG 2021-09: MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers – Link
Application of Regulation on Medical Devices: EU rules to ensure safety of medical devices – Link
EU notification (EU-Switzerland): Status of the EU-Switzerland mutual recognition agreement (MRA) for medical devices – Link
Switzerland is official a third-party country: Today the MepV 812.213 – May 26, 2021 has been published – Link
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
MRA between EU and Switzerland: The Federal Council of Switzerland decided to update MedDO / MepV to act as a third-party country – Link
UDI helpdesk is live: It helps the economic operators in the implementation of the requirements introduced by the new UDI system – Link
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
Update MRA between Switzerland and EU: Information for Swiss Medtech regarding transition period and more – Link
Update of MDCG 2021-1 (Rev.1): Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional – Link
MDCG 2021-4: Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 – Link
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
New Notified Body designated under MDR: Eurofins Expert Services Qy (Nb: 0537) – Link
Notified Bodies under MDR/IVDR: Overview of Notified Bodies at each stage of MDR/IVDR qualification process – Link
MDCG 2021-1: Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional – Link
Factsheets: Factsheets on the main areas of the medical device sector activities – Link
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
SGS FIMKO OY (NB 0598 (ex-0403)) has received its designation under MDR. Check their scope with the following – Link to scope
UDEM Adriatic d.o.o. (NB 2696) has received its designation under MDR. Check their scope with the following – Link to scope
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
TüV Rheinland LGA Products GmbH (NB 0197) has received its designation under IVDR. Check their scope with the following – Link to scope
MDCG 2020-16: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 – Link
MDCG development overview October 2020: Ongoing guidance development within MDCG Subgroups – October 2020 – Link
Overview of Notified Bodies under MDR and IVDR: The EU Commission has updated the designation overview of MDR and IVDR Notified Bodies – Link
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
DQS Medizintechnik GmbH (NB 0297) has received its designation under MDR. Check their scope with the following – Link
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
MDCG 2020-13: The EU-Commission has updated the “Clinical evaluation assessment report template” – Link
MDCG 2018-3 Rev.1: The EU-Commission has updated the “Guidance on UDI for systems and procedure packs” – Link