UK and EU MDR Regulatory Changes, Late 2022
In the past few weeks, we’ve seen a lot of changes.
The three main ones I’m referring to being:
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UK MDR regulations date of entering into force has been pushed back until July 2024.
Annex XVI of EU MDR common specifications have been released.
EU MDR transition dates have been pushed back in a staggered fashion based upon the risk classification of the device.
UK MDR Regulations
The current Medical Device Regulations 2002 (UK MDR 2002) states that the acceptance of CE marked devices on the Great Britain market ends on 30 June 2023.
This has now changed.
Manufacturers will be able to continue to place CE marked devices on the Great Britain market after 1 July 2023. From July 2024, the transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market.
Here is some further detail and guidance if you desire…
Annex XVI Common Specifications
Annex XVI has caused me some headaches in the past three years with several customers, so I can only imagine the turmoil it has caused in a wider circle.
Constantly waiting to see if there are any updates, the spreadsheet still showing the common specifications are going to be published in Q4 2020 (yeah right)…
Well, now we have them and manufacturers can begin to understand a bit more of what the requirements are for products that fall under Annex XVI.
The Common Specifications shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 22 June 2023. However, Article 2(3) shall apply from 22 December 2022.
First of all, what are common specifications?
The MDR and IVDR define Common Specifications as the following:
'"common specifications' [..] means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system."
They are essentially a specific set of requirements, that provides a manufacturer guidance to implement a regulation.
These also have more guidance on the use of clinical evaluation vs clinical investigations - which caused some hassle when the drafted common specifications were released a few months ago.
Here are the Annex XVI Common Specifications if you want to have a proper look.
EU MDR transition dates
Recently, many of my Medical Device Mafia (my network) and I have had a discussion on repeat about when certain decisions and calls are going to be made about the MDR.
You’ve heard all of this before, but the themes are around the number of devices yet to transition to the MDR, along with rising costs of re-certification and extended time periods for assessment by a lack of designated notified bodies.
Furthermore, It is estimated that around 23,000 certificates of conformity for EU medical devices have not yet transitioned, which will expire on May 26, 2024 (if not before).
So, a proposal was developed to enable relevant transition periods for medical devices approved under the Medical Device Directive 93/42/EEC (MDD) to continue to apply until 2027 (for high-risk devices) and 2028 (for medium and low-risk devices).
However, only devices that are “safe” will benefit from the extension.
So what does this mean, this essentially means that manufacturers should continue to progress towards compliance with MDR, as well as appointing a notified body.
What about when my devices certificate expires?
It has been made very clear that only safe and effective devices can continue to be placed on the market when a certificate expires.;
The Medical Device Coordination Group (MDCG) released a position paper on application of Article 97 MDR to legacy devices for which the MDD or AIMD certificate expires before the issuance of the MDR certificate.
You can find the paper here, but it essentially summarises it as:
Manufacturers or authorised representatives should proactively inform the Competent Authority (CA) of the member state around the level of non-compliance with the relevant MDR requirements.
The manufacturer should submit a report containing relevant data gathered through its post-market surveillance system (PMS), in particular data concerning incidents, serious incidents and/or field safety corrective actions.
The CA will then conclude whether the device presents an unacceptable risk to health or safety
The application of Article 97(1) MDR aims to allow the manufacturer to bring the non-compliance to an end within a reasonable period of time.
Periodic Safety Update Reports (PSURs) shall be used to assist.
The CA should define the reasonable period by when the manufacturer should bring the device into compliance; this period should be proportionate to the non-compliance in accordance with Article 97(1) MDR.
So…
That’s it.
Thanks!
Adam