The Netherlands presidency of the Council and representatives of the European Parliament (EP) reached a political agreement on the new Medical Devices Regulations (MDR) and In Vitro Diagnostic Devices Regulations (IVDR) yesterday. The regulations are still subject to approval by the Council's Permanent Representatives Committee and the Parliament's Committee on Environment, Public Health and Food Safety (ENVI).
According to the European Union (EU), both regulations are expected to fulfil a dual aim – they should ensure that medical devices and in vitro diagnostic (IVD) devices are safe, while allowing patients to benefit from innovative health care solutions in a timely manner.
When will the new regulations be published?
Despite having made substantial progress yesterday, LRQA anticipates the regulations will be officially published by Autumn 2016 at the earliest.
LRQA understands that there will be a meeting in Brussels around 17 June 2016, during which the intention is that all parties agree on the final text. Until an agreement is reached, the text can still be subject to change, and will not be officially published until it has been translated into all EU languages and reviewed by the Commission’s legal service department.
Weighing in on the development, Martin Penver, LRQA Head of Notified Body, said, “Now that an agreement for the MDR and IVDR has been reached, there will be an accelerated reading by the EP, and publication of final regulations is expected in Autumn 2016, once the translations are complete. Certain subjects were holding up the agreement, and it will be interesting to view the final text to see whether these have been resolved or moved into the list of future implements and delegating acts.”
What does this mean for medical device manufacturers?
LRQA will continually assess and communicate with the market as well as clients on the key priorities affecting them as a result of the new regulations. Until the EU Commission releases guidance on the full interpretation of the regulations and the effect on re-designation and implementation, the impact on clients and indeed Notified Bodies themselves will be difficult to predict.
For now, LRQA is certain that current certificates issued by LRQA remain valid for the period indicated, and when the transition to the MDR and IVDR starts, the certificate becomes void two years after entry into application at the latest. Applications are expected to apply from 2019 for MDR, and 2021 for IVDR.
Key highlights of the increased requirements in the new regulations
Strengthening the system
- More stringent rules for Competent Authorities and the Notified Bodies they monitor
- Establishing the right and duty of these bodies to conduct unannounced audits on manufacturers
- Explicit requirements for manufacturers to follow up on quality, performance and safety of devices after they are placed on the market
- Improve the availability and accessibility of clinical data of these devices
- Strengthening of protection for patients who take part in clinical investigations
Strengthened rules for high risk devices
- An additional check by experts (e.g. panels and laboratories) for high risk devices such as implants, prior to placing them on the market
- Devices without a medical purpose but with characteristics similar to medical devices will now be covered by the new regulations (e.g. coloured contact lenses for cosmetic purposes)
More transparency for patients and increased traceability
- A central digital database (called Eudamed) will be set up for collecting all relevant information, covering economic operators, Notified Bodies, market surveillance vigilance, clinical investigations, certificates and product information
- Devices will have a unique identification number to enhance traceability throughout the entire supply chain
How will this impact Notified Bodies?
Whilst clearly the increased requirements present a significant increase in workload for Notified Bodies, LRQA welcomes these as a positive step towards achieving the objective of the European Commission’s Joint Action Plan, delivering increased confidence in medical devices and the transparency and rigour of the assessment process itself.
“LRQA is on track from a resource perspective and has already demonstrated this at our Medical Device Directive (MDD) and In Vitro Diagnostic Device Directive (IVDD) re-designation audit. We will apply for MDR and IVDR re-designation from six months after entry into force, and intend to have full scope under the new regulations,” concluded Penver.
About the Medical Device and In Vitro Diagnostic Devices Regulations
The medical regulatory landscape is undergoing its most significant overhaul in years. Triggered by the Poly Implant Prothèse (PIP) breast implants scandal in 2012, the European Commission on 26 September 2012 proposed new regulations to strengthen the existing Medical Devices Directive (MDD 93/42/EEC) and In Vitro Diagnostic Devices Directive (IVDD 98/79/EC).
The proposed regulations introduced several sweeping changes, including tighter and more stringent requirements for medical device manufacturers to ensure patient safety, as well as increased transparency and traceability along the entire supply chain.
Since then, the Recommendation 2013/473/EU was issued to facilitate consistent application of conformity assessments, stipulating additional requirements for conducting unannounced audits and verification of technical documentation for Own Brand Labelling (OBL) manufacturers.
About LRQA’s Medical Device Expertise
With the constantly changing regulatory environment comes a need to stay up-to-date with the latest regulatory intelligence and how the changes impact your organisation.
LRQA’s medical technical experts and industry specialists provide best-in-class medical quality assurance, CE marking product certification to MDD 93/42/EEC and IVDD 98/79/EC, and training services that will equip you with the relevant knowledge at any stage of the product life cycle, towards a timely market launch.
Through our extensive range of training and assessment services, LRQA is helping organisations worldwide remove the uncertainty associated with the changing medical regulatory landscape. For more information about our CE Marking and medical quality assurance services, email us.