09 Dec 2019

Class 1 MDR Self-certification re CE Mark extended by 4 years

MDMS, iso 13485, regulatory affairs, MDR

The European Parliament’s Committee on the Environment, Public Health and Food Safety on Tuesday voted to adopt Corrigendum 2 to the Medical Device Regulations (MDR) that will give manufacturers of certain up-classified Class I devices an additional four years to comply. Corrigendum 2 to MDR was published on Nov 25th and it modifies Article 120(3) of MDR that now reads: '3. By way of derogation ...
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03 Jul 2019

PRRC requirements in MDR and IVDR - new guidance

MDMS, iso 13485, regulatory affairs

EC Guidance regarding a ‘person responsible for regulatory compliance’ (PRRC) The European Commission has recently published 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). Meeting the requirements here will be a challenge for SMEs and start-ups but the ...
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27 Jun 2019

EC admits potential Medical Device supply issues

iso certification, iso 13485, regulatory affairs

EC at last admits potential Medical Device and IVD supply problems in coming years starting May 2020 Despite recent flat denials of problems with Notified Body designation and the medical device industry crying for help or some relief versus the May 2020 deadline for MDR, the European Commission has admitted the potential for supply difficulties in a document. Published  on 17-Jun-19, the ...
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19 Jun 2019

The MDR and IVDR Registration Nightmare - it's getting worse

MDMS, risk management, iso 13485, regulatory affairs

  The European Commission continues to insist that everything is in place for the May 2020 deadline for MDR (2017/45) transition as well as related Notified Body (NB) designation and Eudamed database development.   Objective evidence suggests that this is ‘bunkum’.
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