09 Dec 2019

Class 1 MDR Self-certification re CE Mark extended 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 ...
Read More
11 Nov 2019

Getting the IAF Logo on your ISO 13485 Certificate

accreditation, MDMS, iso 13485

The European Cooperation for Accreditation (EA), an association of 30 national accreditation bodies in Europe, has completed the administrative requirements of the IAF (International Accreditation Forum) necessary for the extension of their IAF multilateral recognition arrangement (MLA) to include ISO 13485.  This omission has in the past, for example, been a barrier for European medical device ...
Read More
11 Oct 2019

MDR IVDR Deadlines, Crash-out Brexit and other disrupters

MDMS, iso 13485, MDR, IVDR

Read More
01 Aug 2019

ISO 13485 Certification for those not making Medical Devices

iso certification, MDMS, iso 13485

ISO Certification for the Medical Device Supply Chain Where do I start if I want to get Certified to ISO 13485? This is a question frequently asked by those involved in the medical device supply chain (e.g. component manufacturers and logistics companies) who have no experience with Medical device manufacture. With a steady, if slow, increase in medical device companies requiring ISO 13485 ...
Read More
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 ...
Read More
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’.
Read More
18 Apr 2019

EU MDR to result in withdrawal of devices from the market

MDMS, risk management, iso 13485, iso 14971

Without an immediate action, tens of thousands of medical devices will be withdrawn from the EU regulatory area next May. MedTech Europe, a European trade association for the medical technology industry including diagnostics, medical devices and digital health, have issued an open letter (dated 15th April 2019) to the European Commission on the implementation and readiness status of the new ...
Read More
05 Apr 2019

Choosing the right Risk Assessment Tool

MDMS, risk management, iso 13485, iso 14971

Using FMEA alone is the lazy choice ISO 14971, Medical devices - Application of risk management to medical devices, and ISO 31010, Risk management -
Read More
14 Feb 2019

ISO 13485 Risk Management and Risk-based Thinking - both required

MDMS, risk management, iso 13485, iso 14971

There are two distinct and different requirements in ISO 13485:2016 for the management of risk.  One relates to the management of the processes that go to make up the ISO 13485 Quality Management system.  And the other relates to patient/end user safety, that is, safety in manufacturing.  The difference between the two is often missed, especially by component manufacturers, as is the issue of ...
Read More
09 Dec 2018

Another Revision of ISO 13485 starts in 2019

MDMS, iso 13485

Why so soon? Last revision published in 2016 and the transition period for migration to this version has not yet ended (due date 31st Mar 2019).  This is indeed a unique situation – a new revision to an ISO management system standard started before the transition to the previous version has been completed.  But why?
Read More